Ansh Labs recalls SARS-CoV2 IgM ELISA test kits due to potential false positives/negatives from labeling updates. Affected kits may cross-react with non-COVID strains.
Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated to remove Plasma as a "sample type" and to update the "limitation" section to include potential cross-reactivity with non-SARS-CoV2 strains.
Ansh Labs is recalling certain SARS-CoV2 IgM ELISA test kits because updated labeling may cause false positive or false negative results. This could lead to incorrect COVID-19 test outcomes if the kit is used without the updated instructions.
The updated instructions remove plasma as a sample type and add warnings about cross-reactivity with non-SARS-CoV2 strains. This could cause false positive or false negative results if the test is used without the revised labeling.
Healthcare providers using the recalled kits for COVID-19 testing may get inaccurate results. Patients relying on these tests for diagnosis could be at risk of incorrect conclusions.
Check for the product code AL-1002 with lot numbers 040720, 041620, 041720, 042420, or 042720-A. These kits were sold between 2021-10-06 and 2021-10-26.
Look for lot numbers 040720, 041620, 041720, 042420, or 042720-A on the kit packaging.
The recall is due to updated labeling that may cause false positive or false negative results from cross-reactivity with non-SARS-CoV2 strains.
Check the lot number to see if it's affected. If it is, you may need to use the kit with the updated instructions to avoid inaccurate results.
The official notice does not mention a specific fix or remedy for the labeling update.
We’ve drafted a message you can send Ansh Labs to request your refund or repair — edit it as you like.
Subject: Recall Z-0842-2021 — Ansh Labs Ansh Labs Hello, I own a Ansh Labs that is covered by recall Z-0842-2021 from Ansh Labs. 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.
