The recall described in this notice is due to the same issue that was announced in the September 17, 2021, Letter to Health Care Providers: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious adverse health consequences or death.
- Software for Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit
- Product Codes and Lot Numbers: See Medical Device Recall Database Entries below in the Additional Resources section.
- Devices Recalled in the United States: 187 software installations are being corrected. This software is used to automate testing with the 9,964,224 distributed tests for Alinity m SARS-CoV-2 Amp Kit (51,897 kits) and 48,192 distributed tests for Alinity m Resp-4-Plex AMP Kit (251 kits). The kits can continue to be used following the implementation of the software correction. If used before the software correction, positive results should be treated as presumptive.
- Distribution Date: May 13, 2020 to August 31, 2021
- Date Initiated by Firm: September 2, 2021
The Alinity m SARS-CoV-2 Assay and the Alinity m Resp-4-Plex are laboratory tests used to detect RNA of SARS-CoV-2—the virus that causes COVID-19. The test uses swab samples taken from the back of the nose and throat (nasopharyngeal) or the back of the mouth and throat (oropharyngeal) or by a procedure that washes the lungs with saline to collect a sample (bronchoalveolar lavage) of people suspected to have an illness caused by the COVID-19 virus. Samples for both tests are taken at a health care setting and require special laboratory processing equipment to get results. The special processing equipment uses software to automate the mixing of the chemicals for the tests.
Reason for Recall
Abbott Molecular, Inc. is recalling the software for the Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits because of the potential to issue false positive results when being used to detect SARS-CoV-2. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. The false positive results may be related to the current mixing parameters for the chemicals that are combined with patient samples to detect the viruses. In some cases, the mixing parameters may cause a sample in one well of the machine’s tray to overflow into another sample well. Overflow into the wells of true negative samples that are positioned near positive samples in the tray could produce false positive results.
A false positive result for SARS-CoV-2 could lead to:
- Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19.
- Further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results.
- The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects.
- People not taking recommended precautionary measures against COVID-19, including vaccination.
- Isolation measures, including monitoring of household or other close contacts for symptoms, limiting contact with family or friends, and missing school or work.
There have been no deaths or adverse health consequences reported from use of this test.
Who May Be Affected
- People who received a positive test result for SARS-CoV-2 detected by Alinity m SARS-CoV-2 Assay or Alinity m Resp-4-Plex Assay
- Clinical laboratory staff and health care providers who have tested patient samples for SARS-CoV-2 using Alinity m SARS-CoV-2 Assay or Alinity m Resp-4-Plex
What to Do
On September 2, 2021, Abbott Molecular, Inc. issued an Urgent Field Safety Notice/Field Correction Recall to all impacted customers requesting that they:
- Complete and return an acknowledgement letter that the notice was received.
- Consider all positive SARS-CoV-2 test results presumptive until the company can implement updated software specification files to correct the issue at each customer’s laboratory site.
The FDA issued a letter to clinical laboratory staff and health care providers on September 17, 2021 recommending that health care providers and clinical laboratory staff:
- Consider any positive SARS-CoV-2 result from tests using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits to be presumptive until the company can implement updated software specification files to correct the issue at each laboratory site.
- Consider retesting positive patient specimens from tests performed in the last two weeks with an alternate authorized SARS-CoV-2 test.
- Consider communicating to patients who received positive results using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits from June 2021 through the present to let them know that they may have had a false positive test result.
- Report any issues with using COVID-19 tests to the FDA.
Customers with questions about this recall should call Abbott Technical Support at 1-800-553-7042, Option 2 or contact the local Molecular Diagnostics Abbott representative in your area.
- Medical Device Recall Database Entries
- Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.