Incident: False Positive Results in Abbott COVID-19 Test Kits.

Published Date: 2021-10-14

Postmortem Analysis
Timeline 1. The software failure incident with Abbott Laboratories' COVID-19 test kits happened in September 2021 as per the article [120519]. 2. Published on 2021-10-14 07:00:00+00:00. 3. The software failure incident occurred in September 2021.
System 1. Alinity m SARS-CoV-2 AMP test kit 2. Alinity m Resp-4-Plex AMP test kit 3. Software used at the laboratories where the samples are processed [120519]
Responsible Organization 1. Abbott Molecular Inc, a unit of Abbott Laboratories, was responsible for causing the software failure incident by issuing COVID-19 laboratory test kits that could potentially issue false positive results [Article 120519].
Impacted Organization 1. Healthcare providers and clinical laboratories were impacted by the software failure incident with the Abbott Laboratories' Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP test kits, which could potentially issue false positive results [Article 120519].
Software Causes 1. The software used in the Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP test kits by Abbott Molecular Inc was causing an overflow of one patient sample into another while mixing chemicals, potentially leading to false positive results [120519].
Non-software Causes 1. An overflow of one patient sample into another while mixing chemicals with the samples was identified as a cause of the false positive results [Article 120519].
Impacts 1. The software failure incident led to the potential issuance of false positive results in COVID-19 laboratory test kits by Abbott Laboratories, specifically the Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP test kits [Article 120519]. 2. Healthcare providers and clinical laboratories were cautioned about the potential for false positive results with the affected tests, leading to the recommendation of retesting positive patient samples with another authorized COVID-19 test [Article 120519]. 3. The incident required impacted customers to consider all positive COVID-19 test results presumptive until software updates could be implemented to correct the issue at the laboratory sites [Article 120519].
Preventions 1. Implementing thorough software testing procedures before releasing the software for use could have potentially prevented the software failure incident [120519]. 2. Conducting regular software maintenance and updates to address any identified issues or vulnerabilities could have helped prevent the incident [120519].
Fixes 1. Implementing software updates to correct the issue at the customers' laboratory sites [120519].
References 1. U.S. Food and Drug Administration (FDA) [Article 120519] 2. Abbott Molecular Inc [Article 120519]

Software Taxonomy of Faults

Category Option Rationale
Recurring one_organization The software failure incident related to the Abbott Laboratories' COVID-19 test kits has happened again within the same organization. The article mentions that Abbott Molecular Inc, a unit of Abbott Laboratories, had issued a notice on September 2 asking impacted customers to consider all positive COVID-19 test results presumptive until software updates were implemented to correct the issue at the customers' laboratory sites [120519]. This indicates a recurrence of the software failure incident within the same organization.
Phase (Design/Operation) design (a) The software failure incident in Article 120519 is related to the design phase. The issue with the Abbott Laboratories' COVID-19 test kits was caused by an overflow of one patient sample into another during the mixing of chemicals, which was facilitated by the software used at the laboratories where the samples are processed. This design flaw in the software led to false positive results in the tests, prompting the FDA to issue a Class 1 recall [120519].
Boundary (Internal/External) within_system (a) The software failure incident related to the Abbott Laboratories' COVID-19 test kits was within the system. The issue was identified with the software used at the laboratories where the samples are processed to automate the mixing of chemicals. The FDA mentioned that an overflow of one patient sample into another while mixing chemicals with the samples could be related to the false positive results, indicating an internal software issue [Article 120519].
Nature (Human/Non-human) non-human_actions (a) The software failure incident in this case was related to non-human actions. The issue was identified as an overflow of one patient sample into another while mixing chemicals with the samples, which could lead to false positive results in the COVID-19 test kits. This overflow was a result of the software used to automate the mixing of chemicals at the laboratories, indicating a failure introduced without human participation [120519].
Dimension (Hardware/Software) hardware (a) The software failure incident in this case is related to hardware. The recall of the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP test kits by Abbott Laboratories was due to a potential issue with the software used to automate the mixing of chemicals in the laboratories where the samples are processed. The FDA identified that an overflow of one patient sample into another while mixing chemicals with the samples could lead to false positive results, indicating a hardware-related issue [120519].
Objective (Malicious/Non-malicious) non-malicious (a) The software failure incident related to the Abbott Laboratories' COVID-19 test kits was non-malicious. The incident involved the potential for false positive results due to an overflow of one patient sample into another while mixing chemicals with the samples, which was related to the software used to automate the mixing of chemicals at the laboratories [120519].
Intent (Poor/Accidental Decisions) accidental_decisions (a) The software failure incident related to the Abbott Laboratories' COVID-19 test kits was not explicitly attributed to poor decisions. However, it was mentioned that the issue with the test kits potentially issuing false positive results was related to an overflow of one patient sample into another while mixing chemicals with the samples, which could be a result of a flaw in the software used to automate the mixing process [120519]. This indicates a technical flaw rather than a poor decision-making process.
Capability (Incompetence/Accidental) development_incompetence (a) The software failure incident related to development incompetence is evident in the article. The FDA identified a recall of two COVID-19 laboratory test kits by Abbott Laboratories due to the potential issuance of false positive results. The issue was linked to an overflow of one patient sample into another during the mixing of chemicals, which was facilitated by the software used at the laboratories where the samples are processed [120519]. This indicates a failure in the design or implementation of the software, possibly due to a lack of professional competence in ensuring proper sample segregation and processing. (b) The software failure incident does not appear to be related to accidental factors but rather to issues with the software design and implementation as mentioned in the article [120519].
Duration temporary The software failure incident related to the Abbott Laboratories' COVID-19 test kits was temporary. The issue was identified in the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP test kits, which required a software for automating the mixing of chemicals in laboratories processing the samples. The FDA recommended retesting positive patient samples with another authorized COVID-19 test until software updates could be implemented to correct the issue at the customers' laboratory sites [Article 120519].
Behaviour other (a) crash: The software failure incident in this case does not involve a crash where the system loses state and does not perform any of its intended functions. The issue with the Abbott Laboratories' COVID-19 test kits was related to potential false positive results due to an overflow of one patient sample into another during the mixing of chemicals, which was facilitated by the software used in the laboratories [120519]. (b) omission: The software failure incident is not characterized by omission, where the system omits to perform its intended functions at an instance(s). The issue here is more about the generation of false positive results rather than the omission of performing functions [120519]. (c) timing: The software failure incident is not related to timing, where the system performs its intended functions correctly but too late or too early. The issue with the test kits was not about timing but about the potential for false positive results due to a mixing error facilitated by the software [120519]. (d) value: The software failure incident does not involve a failure due to the system performing its intended functions incorrectly. The issue with the Abbott Laboratories' test kits was not about incorrect functioning but about the potential for false positive results caused by a specific error related to sample mixing [120519]. (e) byzantine: The software failure incident does not exhibit a byzantine behavior, where the system behaves erroneously with inconsistent responses and interactions. The issue with the test kits was more straightforward, involving a specific error in the mixing process that could lead to false positive results [120519]. (f) other: The behavior of the software failure incident in this case could be categorized as a specific error in the mixing process facilitated by the software, leading to potential false positive results in COVID-19 testing. This behavior does not fit neatly into the categories of crash, omission, timing, value, or byzantine behaviors [120519].

IoT System Layer

Layer Option Rationale
Perception actuator, processing_unit, embedded_software (a) The software failure incident related to the Abbott Laboratories' COVID-19 test kits was not specifically mentioned to be related to a sensor error. (b) The article mentioned that the issue with the test kits was related to an overflow of one patient sample into another while mixing chemicals with the samples, which could be related to false positive results. This indicates a potential actuator error introduced during the mixing process [120519]. (c) The software used at the laboratories to automate the mixing of chemicals was identified as a contributing factor to the false positive results. This points to a processing_unit error in the software that led to the failure [120519]. (d) The article did not mention any network communication errors as contributing factors to the software failure incident. (e) The software used for automating the mixing of chemicals in the COVID-19 test kits was identified as a contributing factor to the false positive results. This indicates an embedded_software error in the system [120519].
Communication unknown The software failure incident reported in Article 120519 was not related to the communication layer of the cyber physical system that failed. The failure was specifically related to the software used at laboratories to automate the mixing of chemicals during COVID-19 testing, which led to potential false positive results in the test kits. The issue was identified as an overflow of one patient sample into another while mixing chemicals with the samples, which could result in false positives. The FDA recommended retesting positive patient samples with another authorized COVID-19 test due to the potential for false positives caused by the software issue.
Application FALSE The software failure incident related to the Abbott Laboratories' COVID-19 test kits was not explicitly mentioned to be related to the application layer of the cyber physical system. The failure was primarily attributed to the potential for false positive results due to an overflow of one patient sample into another while mixing chemicals with the samples, which was addressed through software updates [Article 120519]. Therefore, it is unknown whether the failure was specifically related to the application layer as defined.

Other Details

Category Option Rationale
Consequence no_consequence (a) death: People lost their lives due to the software failure (b) harm: People were physically harmed due to the software failure (c) basic: People's access to food or shelter was impacted because of the software failure (d) property: People's material goods, money, or data was impacted due to the software failure (e) delay: People had to postpone an activity due to the software failure (f) non-human: Non-human entities were impacted due to the software failure (g) no_consequence: There were no real observed consequences of the software failure (h) theoretical_consequence: There were potential consequences discussed of the software failure that did not occur (i) other: Was there consequence(s) of the software failure not described in the (a to h) options? What is the other consequence(s)? The articles do not mention any consequences such as death, harm, basic needs impact, property loss, or non-human impact resulting from the software failure incident. The FDA stated that no deaths or adverse health consequences have been reported from the use of the faulty COVID-19 test kits. The primary consequence discussed was the potential for false positive results and the need for retesting positive patient samples with another authorized COVID-19 test to ensure accurate results. Therefore, the incident falls under the category of "no_consequence" as there were no reported real observed consequences of the software failure [120519].
Domain health (a) The software failure incident reported in Article 120519 is related to the health industry. The incident involved the recall of two COVID-19 laboratory test kits by Abbott Laboratories due to the potential for false positive results. The tests required a software system to automate the mixing of chemicals in the laboratories where the samples were processed [120519].

Sources

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