# FDA recall Z-2256-2021

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-07-01.

## Product

Access SARS-CoV-2 Antigen  Calibrators, Catalog, REF:  C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI:  (01)15099590742720;

## Reason for recall

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

## Distribution

US Nationwide Distribution in the states of  Alabama Alaska 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, Wisconsin    OUS: New Zealand, Libya

## Key facts

- **Recall number:** Z-2256-2021
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-01
- **Report date:** 2021-08-18
- **Termination date:** 2023-06-14

- **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-2256-2021

## Citation

> AI Analytics. FDA recall Z-2256-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-2256-2021. Source: US FDA. Licensed CC0.

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