# FDA recall Z-1670-2021

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-04-14.

## Product

Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e

## Reason for recall

specimens collected in transport media may result is false negative results when stored in certain conditions.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia and the country of New Zealand.

## Key facts

- **Recall number:** Z-1670-2021
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-14
- **Report date:** 2021-06-02
- **Termination date:** 2023-05-19

- **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-1670-2021

## Citation

> AI Analytics. FDA recall Z-1670-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1670-2021. Source: US FDA. Licensed CC0.

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