# FDA recall Z-2508-2021

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-08-05.

## Product

Access SARS CoV-2 IgG (1st IS) Assay:    Access Immunoassay Systems REAGENT PACK, REF C74339    Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340    Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

## Reason for recall

Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute

## Distribution

U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA.

## Key facts

- **Recall number:** Z-2508-2021
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-05
- **Report date:** 2021-09-29
- **Termination date:** 2023-06-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2508-2021

## Citation

> AI Analytics. FDA recall Z-2508-2021. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-2508-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*