# FDA recall Z-0997-2026

> **Beckman Coulter Ireland, Inc.** · Class II · device recall initiated 2025-10-14.

## Product

BECKMAN COULTER BICARBONATE REF:  OSR6137  OSR6237  OSR6637    OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

## Reason for recall

Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guan, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Brazil, Canada, Ecuador, Ireland, Mexico, Netherlands, Panama, Taiwan, and Province of China.

## Key facts

- **Recall number:** Z-0997-2026
- **Recalling firm:** Beckman Coulter Ireland, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-14
- **Report date:** 2025-12-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** O'Callaghan'S Mills, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0997-2026

## Citation

> AI Analytics. FDA recall Z-0997-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0997-2026. Source: US FDA. Licensed CC0.

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