Z-0997-2026Class II

BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the...

Name: Z-0997-2026 BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the...
Creator: Beckman Coulter Ireland, Inc.
Published: 2025-10-14
License: https://open.fda.gov/license/

Beckman Coulter Ireland Inc / initiated 2025-10-14 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Ireland, Inc. began a recall of BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human... on 2025-10-14. FDA classified it as Class II and gives the reason as "Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0997-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-14
Posted: 2025-12-23
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.
Product code: KHS Enzymatic, Carbon-Dioxide
Reason for recall: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Root cause tag: manufacturing process
FDA 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0997-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0997-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23

Product code KHS

K131546Class IIAu Bicarbonate ReagentBeckman Coulter Ireland, Inc. / cleared 2013-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)