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

FDA device recall Z-0997-2026 · posted 2025-12-23 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Ireland, Inc.

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KHS

Quantity affected

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,

Date initiated

2025-10-14

Date posted

2025-12-23

Location

Mills, Ireland

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