Abbott Molecular, Inc. is recalling 2,103 Alinity m Resp-4-Plex Amplification (AMP) Kits because they have shown an increase in false positive results and reactive negative controls. These kits are used to test for influenza A, influenza B, Respiratory Syncytial Virus (RSV), and SARS-CoV-2 (COVID-19) in patients with respiratory symptoms. While no injuries have been reported, using these tests can lead to incorrect diagnoses and unnecessary treatments. Diagnostic laboratories and healthcare providers using these kits should stop using the affected lots and contact the manufacturer for replacement or correction.
A false positive result means a patient may be told they have an infection that they do not actually have, which can lead to unnecessary isolation, unneeded medication, and a delay in diagnosing their actual illness. There have been reports of an increase in reactive negative controls and false positive results using these specific kits.
Quantity: 1447 units. Intended for qualitative detection and differentiation of RNA from influenza A, influenza B, RSV, and SARS-CoV-2.
Quantity: 656 units. Intended for simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or RSV.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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