# FDA recall Z-0875-2021

> **Beckman Coulter Inc.** · Class II · device recall initiated 2020-12-30.

## Product

ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

## Reason for recall

The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.

## Key facts

- **Recall number:** Z-0875-2021
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-30
- **Report date:** 2021-01-27
- **Termination date:** 2022-09-19

- **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-0875-2021

## Citation

> AI Analytics. FDA recall Z-0875-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0875-2021. Source: US FDA. Licensed CC0.

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