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.
Take action
Contact the company
📍Recalling firmAnsh Labs, LLC445 W Medical Center Blvd · Webster, TX 77598-4217
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/63637-ansh-labs-sars-cov2-igm-elisa-kit-recall-false-results.
“Ansh Labs SARS-CoV2 IgM ELISA Kit Recall: False Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63637-ansh-labs-sars-cov2-igm-elisa-kit-recall-false-results. Based on FDA recall #Z-0842-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0842-2021%22&limit=1).
The FDA announced on Dec. 18, 2020, that Ansh Labs, LLC is recalling its SARS-CoV2 IgM ELISA test kits due to labeling errors that may cause false positive or negative results. The agency said the recall addresses a need to update the instructions for use regarding sample types and cross-reactivity limitations.
Lot codes and expiration dates: 040720/2021-10-06, 041620/2021-10-15, 041720/2021-10-18, 042420/2021-10-15, 042720-A/2021-10-26
Distribution: US Nationwide including TX, MO, OK, MD, FL, NY, OR, GA, NC
The hazard
According to the FDA, the recall is due to a labeling update intended to reduce the risk of false positive or false negative results. The instructions for use are being modified to remove Plasma as a sample type and to include potential cross-reactivity with non-SARS-CoV2 strains in the limitation section.
Context
GovInfoNow's records show other recent recalls of similar products include Sperm Ab ELISA Test Kit Recall (2026-07-02), Aniara Diagnostica ZYMUTEST HIA IgG Kit Recall (2026-04-01), and Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24).
How to tell if you have this one
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.
Brand
Ansh Labs
Product
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for lot numbers 040720, 041620, 041720, 042420, or 042720-A on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of TX, MO, OK, MD, FL, NY, OR, GA, NC. OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Maryland, Missouri, New York, North Carolina, Oklahoma, Oregon, Texas.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0842-2021 (December 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0842-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.