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Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL recallZ-1606-2023 · Beckman Coulter Inc. · initiated Apr 5, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1606-2023
Status
Open, Classified
Initiated by the company
Apr 5, 2023
Posted by the FDA
May 18, 2023
Recalling firm
Beckman Coulter Inc.
Quantity
48,633 units in total
Product code
KHS
FDA submissions
K131546
Distribution
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,

Product description

Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

Code information (models, lots, serial numbers)

All Lots: UDI-GI: 15099590020187

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K131546 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92071).

Sources and updates

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