Abbott Labs Issues Recall on Certain Covid‑19 Test Kits
In an unexpected turn of events, Abbott Laboratories’ specialized unit, Abbott Molecular, has pulled a Class 1 recall for two of its Covid‑19 test kits—the Alinity m SARS‑CoV‑2 AMP and the Alinity m Resp‑4‑Plex AMP. These kits may produce false positives, according to the US Food and Drug Administration on Thursday, Oct 14.
Why the Recall?
- The FDA cautioned clinicians in September that when mixing chemicals and mishandling samples, one drop can “overflow” into another—potentially pushing the test into a false‑positive zone.
- As a result, laboratories are advised to double‑check any positive patient samples with a different, FDA‑approved Covid‑19 test.
- No reports of deaths or serious health complications have surfaced from the use of these kits so far.
Abbott’s Covid‑19 Arsenal
Abbott isn’t just known for these two test kits. Over the peak of the pandemic last year, the company’s broad lineup of antigen, molecular, and serology tests significantly boosted its earnings. Though the recall is a surface‑level hiccup, it reminds us how critical accurate testing remains.
Bottom Line
If you’re a healthcare professional or lab technician, flag any suspicious results from the Alinity m kits and consider a backup test. Meanwhile, Abbott’s overall contributions to Covid‑19 diagnostics remain a solid part of the battle against the virus.
