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U.S. Department of Health and Human Services

Class 2 Device Recall Access Thyroglobulin

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 Class 2 Device Recall Access Thyroglobulinsee related information
Date Initiated by FirmJuly 10, 2025
Date PostedAugust 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2322-2025
Recall Event ID 97255
510(K)NumberK031269 
Product Classification System, test, thyroglobulin - Product Code MSW
ProductAccess Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Code Information UDI-DI: 15099590227173; Lot Number: 439163
FEI Number 2122870
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information ContactIan Pilcher
952-448-4848
Manufacturer Reason
for Recall		Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE RECALL notification dated 7/2/25 was sent to customers. ACTION: " Discontinue using Access Thyroglobulin reagent lot 439163 and discard all remaining reagent packs from this lot. " At the discretion of the medical director, a retrospective review of patient results generated with Access Thyroglobulin reagent lot 439163 should be performed, which includes reviewing patient history, to assess the need for retesting. " Please contact your local Beckman Coulter representative for replacement product requests and to receive updates on availability and delivery. RESOLUTION: Beckman Coulter is investigating the root cause of this issue to prevent similar occurrences. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: " From our website: http://www.beckmancoulter.com " Contact your local Beckman Coulter Representative for replacement.
Quantity in Commerce453 units
DistributionWorldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
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 = MSW
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