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Class 2 Device Recall Beckman Coulter BICARBONATE |
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Date Initiated by Firm |
April 05, 2023 |
Date Posted |
May 18, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1608-2023 |
Recall Event ID |
92071 |
510(K)Number |
K131546
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Product Classification |
Enzymatic, carbon-dioxide - Product Code KHS
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Product |
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
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Code Information |
All Lots: UDI-GI: 15099590060206 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact |
Marguerita Sweeney 1800-854-3633
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Manufacturer Reason for Recall |
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
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 |
Quantity in Commerce |
48,633 units in total |
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, |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = KHS and Original Applicant = BECKMAN COULTER IRELAND INC
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