# FDA recall Z-1126-2021

> **Confirm Biosciences Inc** · Class II · device recall initiated 2021-01-29.

## Product

Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole  Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.

## Reason for recall

Due to two (2) issues:  1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories.  2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of  Australia, Mexico, Honduras, Spain, Sierra Leone, Bahamas, Ecuador, Turkey, Romania, Kuwait, Libya, Qatar, Ghana, Argentina, Bolivia, Brazil, Guatemala, Panama, India, United Kingdom, West Indies, South Africa, United Arab Emirates, Slovenia, Canada, Israel, United Kingdom, Romania, Argentina,  Honduras, Russian Federation, R¿publique D¿mocratique du Congo, Switzerland, Dominican Republic, Greece, Saudi Arabia, and Portugal.

## Key facts

- **Recall number:** Z-1126-2021
- **Recalling firm:** Confirm Biosciences Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-29
- **Report date:** 2021-02-24
- **Termination date:** 2022-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1126-2021

## Citation

> AI Analytics. FDA recall Z-1126-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1126-2021. Source: US FDA. Licensed CC0.

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