# FDA recall Z-0842-2021

> **Ansh Labs, LLC** · Class II · device recall initiated 2020-12-18.

## 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.

## Reason for recall

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.

## Distribution

US Nationwide distribution including in the states of TX, MO, OK, MD, FL, NY, OR, GA, NC. OUS: None

## Key facts

- **Recall number:** Z-0842-2021
- **Recalling firm:** Ansh Labs, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-18
- **Report date:** 2021-01-20
- **Termination date:** 2022-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Webster, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0842-2021

## Citation

> AI Analytics. FDA recall Z-0842-2021. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-0842-2021. Source: US FDA. Licensed CC0.

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