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U.S. Department of Health and Human Services

Class 2 Device Recall Access

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 Class 2 Device Recall Accesssee related information
Date Initiated by FirmSeptember 05, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0265-2025
Recall Event ID 95407
510(K)NumberK112933 
Product Classification Immunochemical, thyroglobulin autoantibody - Product Code JNL
Product Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
Code Information All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.
FEI Number 2122870
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information ContactCourtney Walton
952-448-4848
Manufacturer Reason
for Recall		IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
FDA Determined
Cause 2		Error in labeling
ActionThe recalling firm issued letters dated August 28, 2024, which were issued 9/5/2024 via email and first class mail. The letter describes the issue, impact, and actions that should be taken. The consignee is to retain a copy of the letter as it serves as current labeling regarding biotin interference with the Access Thyroglobulin Antibody II assay. Appendix A of the letter provides the incorrect and correct sections of the IFUs. The recalling firm recommends sharing the content of the letter with their laboratory and/or medical director to assess the need for retesting. The letter informs the consignee that Beckman Coulter will update the IFUs to contain accurate biotin interference claims for the assay. Notifications will be sent when the updated IFU is available for download from the Beckman Coulter website. The letter also reports that IFU part number A38168 has been retired and will not be updated. If the affected product has been forwarded to another laboratory, the consignee is requested to provide them a copy of the letter. The consignee is to respond within 10 days electronically via email or manually by completing and returning the enclosed response form.
Quantity in Commerce465,481 kits
DistributionDistribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military distribution. Foreign distribution was made to Mexico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JNL
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