Quidel recalls Lyra SARS-CoV-2 Assay (M120) reagents with specific lot numbers due to rare false negative results when viral load is high and Ct values drop below 5.
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
Quidel is recalling specific lots of their Lyra SARS-CoV-2 Assay (M120) test reagents. The recall is for rare cases where high viral loads might cause false negative results if the test shows Ct values of 5 or lower. This could lead to incorrect negative results for SARS-CoV-2 infections.
In rare cases, samples with very high SARS-CoV-2 viral loads can produce test results with Ct values of 5 or lower. These results might be misinterpreted as negative when the actual sample is positive. However, no formal complaints of false negatives have been reported among users of this test.
Users of the Lyra SARS-CoV-2 Assay (M120) reagents with specific lot numbers listed in the recall. People testing for SARS-CoV-2 with high viral loads may be at slightly higher risk of false negatives.
Check the lot number on the reagent packaging. The affected lots include specific numbers like 031620A, 031620B, 031620C, 032320, and others listed in the recall notice.
Look for the lot number on the reagent packaging to determine if it is affected by this recall.
The recall is for rare cases where high viral loads might cause false negative results if the test shows Ct values of 5 or lower. No formal complaints of false negatives have been reported.
Check the lot number on the reagent packaging. If it matches the listed affected lots, you should stop using it and contact Quidel for further instructions.
This is a low-risk situation as it only affects rare cases with very high viral loads and no formal complaints of false negatives have been reported.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1928-2021 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1928-2021 from Quidel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
