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.

Recall number

Z-0997-2026

Recalling firm

Beckman Coulter Ireland, Inc.

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.

Status

Open, Classified

Initiated

2025-10-14

Posted

2025-12-23

Terminated

not on file

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 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

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.

Lot, serial or model codes

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

510(k) numbers

["K131546"]

PMA numbers

not on file

Product code

KHS

Firm FEI

1000206808

Firm city

Mills

Firm state

not on file

Firm country

Ireland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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