Recall Z-0997-2026 ยท KHS Enzymatic, Carbon-Dioxide
Beckman Coulter Ireland, Inc.
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.
| Date | Dec 23, 2025 (initiated Oct 14, 2025) |
| Status | Open, Classified |
| Reason | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/14/2025, the firm sent via US Postal and email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that complaints have been received for elevated results generated using Bicarbonate reagent when there are high levels of lactate Dehydrogenase (LDH) in the test samples. Beckman Coulter has investigated and confirmed that the lots listed above of Bicarbonate reagent may generate Bicarbonate results that are biased high due to interference with LDH in the test sample. Customers are instructed to: "Discontinue use and dispose all Bicarbonate OSR6x37 lots listed in Table A i |
| Quantity | 36,981 reagents (U.S.-35,320, O.U.S.-1,661) |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131546 | AU BICARBONATE REAGENT Beckman Coulter Ireland, Inc., Oct 9, 2013 |