FDA recall Z-0997-2026

Beckman Coulter Ireland, Inc. · Class II · device

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

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

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