Class II — Ansh Labs, LLC
| Recalling firm | Ansh Labs, LLC |
|---|---|
| Registered facility | ANSH LABS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider. |
| Quantity | 327 kits (93 test per kit) |
| Distribution | US Nationwide distribution including in the states of TX, MO, OK, MD, FL, NY, OR, GA, NC. OUS: None |
| Initiated | 2020-12-18 |
| Classified | 2021-01-11 |
| Terminated | 2022-01-11 |
| Recall number | Z-0842-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ansh Labs, LLC (Z-0842-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87057/
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