—#199619

Product

Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

FDA product code: KHS — Enzymatic, Carbon-Dioxide
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K131546
Affected lot / code info: All Lots: UDI-GI: 15099590060206

Why it was recalled

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On April 5, 2023, Beckman Coulter (BEC) issued a "URGENT MEDICAL DEVICE RECALL" Notification via mail and/or E-Mail. In addition, to informing consignees about the recalled product, BEC asked consignees to take the following actions: 1. Safely dispose of the Bicarbonate lot numbers that are specifically described in Table A. 2. If replacement or re-imbursement of the above lots is required, customers are directed to contact their local Beckman Coulter representative for replacement and re-imbursement. 3. Customers are advised to implement the adjusted Calibration OD range using the instructions within the customer letter to avoid generation of elevated results for all other Bicarbonate lots. 4. Retrospective review of patient data is not required due to the remote possibility of generating falsely elevated, clinically impactful results which could cause a change in treatment. Please share the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 4. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forward any of the affected products(s) listed above to another laboratory, please provide them a copy of the letter. 5. Please respond within 10 days in one of the following ways: - Electronically, you received this communication via email. - Manually, complete and return the enclosed Response Form. 6. If you have any questions, please call 1-800-854-3633

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,

Timeline

Recall initiated: 2023-04-05
Posted by FDA: 2023-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199619. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.