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Beckman Coulter Ireland, Inc. recalls BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitat
Recalled December 31, 2025 · FDA recall Z-0997-2026 · Beckman Coulter Ireland
Hazard
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. · FDA Class II
Units
36,981 reagents (U.S.-35,320, O.U.S.-1,661)
Sold at
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.
Description
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
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.
Manufacturer(s)
Beckman Coulter Ireland, Inc.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →