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# Abbott Molecular Alinity Covid Kit Recall is Class 1
- URL: https://www.fdaweb.com/abbott-molecular-alinity-covid-kit-recall-is-class-1/
- Published: 2021-10-14T12:00:00.000Z
- Updated: 2026-09-14T17:18:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150372

FDA says the 9/2 Abbott Molecular recall of its Alinity m SARS-Cov-2 AMP kit and Alinity m Resp-4-Plex AMP kit is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/abbott-molecular-inc-recalls-alinity-m-sars-cov-2-amp-kit-and-alinity-m-resp-4-plex-amp-kit?ref=fdaweb.com) says 187 software installations are being corrected to automate testing with the 9,964,224 distributed tests for Alinity m SARS-Cov-2 AMP kits (51,897 kits) and 48,192 distributed tests for Alinity m Resp-4-Plex kit (251 kits).

Both of the units are laboratory tests used to detect RNA of SARS-CoV-2, the virus that causes Covid-19\. The test uses swab samples taken in a healthcare setting and requires special laboratory processing equipment to get results, FDA says. The equipment uses software to automate the mixing of the chemicals for the tests.

Abbott recalled the kits because they have the potential to issue false-positive results when being used to detect SARS-CoV-2, the notice says.

In a [letter](https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-positive-results-abbott-molecular-inc-alinity-m-sars-cov-2-amp-and-alinity-m-resp-4?ref=fdaweb.com) to clinical laboratory staff and healthcare providers, FDA says the false-positive results may be related to current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. The letter contains recommendations for clinical laboratory staff and healthcare providers.