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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter Access Thyroglobulin Reagents on the Access Immunoassay Systems

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  Class 2 Device Recall Beckman Coulter Access Thyroglobulin Reagents on the Access Immunoassay Systems see related information
Date Initiated by Firm July 06, 2023
Date Posted October 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-0100-2024
Recall Event ID 92670
510(K)Number K031269  
Product Classification System, test, thyroglobulin - Product Code MSW
Product Access Thyroglobulin Calibrators
Code Information UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information Contact Adam Viitala
714-993-5321
Manufacturer Reason
for Recall		 It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
FDA Determined
Cause 2		 Other
Action Beckman Coulter issued an Urgent Medical Device Recall letter dated 06/28/2023 to its consignees affected worldwide on 07/06/2023 via email or letter and followed with an updated letter (dated 07/07/2023) issued on 07/14/2023 which contained FDA suggested edits. The notice explained the problem, the risk to the patient and requested the following actions be taken: If you have downloaded the alternative calibrator card issued in April 2023, please discard that calibrator card, and do not use it moving forward. . Only use Access Thyroglobulin calibrator lots 338013 or higher to calibrate Access Thyg reagent packs (C71762), when this becomes available in your laboratory. . Continue to use any lot of Thyroglobulin Calibrator (PN 33865) with Access Thyroglobulin Reagent packs (33860). The firm issued an Important Product Notification letter was issued on 2023 August 10 notifying customers in the US, Canada, and China that they were NOT affect by this issue and to disregard the prior Urgent Medical Device Recall letters.
Quantity in Commerce 5980 units
Distribution worldwide except US, Canada, and China
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = MSW and Original Applicant = BECKMAN COULTER, INC.
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