Class 2 Device Recall Bicarbonate AU analyzer reagent

• Date Initiated by Firm: October 14, 2025
• Date Posted: December 23, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0997-2026
• Recall Event ID: 97842
• 510(K)Number: K131546
• Product Classification: Enzymatic, carbon-dioxide - Product Code KHS
• 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.
• Code Information: Catalog Numbers / UDI-DI codes: OSR6137 - 15099590020187 Lot Numbers: 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2693 2694 2695 2696 OSR6237 - 15099590010348 Lot Numbers: 2702 2703 2704 2705 2706 2707 2708 2709 2710 2712 2713 2714 2715 2716 OSR6637 - 15099590060206 Lot Numbers: 2726 2728 2729 2730 2731 2732 2733 2734 2736 2737 2738 2739
• Recalling Firm/ Manufacturer: Beckman Coulter Ireland, Inc.; Lismeehan; O'Callaghan'S Mills Ireland
• For Additional Information Contact: Marguerita Sweeney; (0)65 683 1100
• Manufacturer Reason for Recall: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
• FDA Determined 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 in the ISSUE section of this letter, following their laboratory protocols and local regulations. Contact their local Beckman Coulter representative for replacement or re-imbursement. "For Bicarbonate OSR6x37 lots listed in Table B in the ISSUE section if elevated LDH levels are suspected, please assess results in conjunction with patient s LDH values. "Share the content of this letter with their laboratory and/or Medical Director to evaluate the requirement for a retrospective review of Bicarbonate results for neonatal patients and patients with elevated LDH levels. o Complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR o Call Client Services at (800) 526-3821 For questions, contact Customer Support Center. "From Beckman Coulter's website: http://www.beckmancoulter.com "By phone: call 1-800-854-3633 in the United States.
• Quantity in Commerce: 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, Brazil, Canada, Ecuador, Ireland, Mexico, Netherlands, Panama, Taiwan, and Province of China.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KHS