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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Beckman Coulter Bicarbonate Reagent recalled for falsely high test results

Beckman Coulter
FALSE CLAIMSNationwide distribution

Stop using affected Beckman Coulter Bicarbonate Reagent

Beckman Coulter Bicarbonate Reagent (catalog numbers OSR6137, OSR6237, OSR6637) used in laboratory analyzers may produce falsely high bicarbonate test results. This happens because a substance in blood samples called Lactate Dehydrogenase (LDH) interferes with the test. Affected lot numbers are listed in specific ranges for each catalog number.

  • Check your laboratory's inventory for the affected catalog numbers (OSR6137, OSR6237, OSR6637) and lot numbers listed in the recall notice
  • Stop using affected reagent lots immediately
  • Contact Beckman Coulter or your reagent supplier for replacement or refund instructions
  • Review any patient test results from affected reagent batches with your healthcare provider
Hazard

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

Sold states
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.
Affected count
36,981 reagents (U.S.-35,320, O.U.S.-1,661)
Manufactured in
Lismeehan, N/A, O'Callaghan'S Mills, N/A, Ireland
Products
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.

Official notice

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

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