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U.S. Department of Health and Human Services

Class 2 Device Recall Access Testosterone

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 Class 2 Device Recall Access Testosteronesee related information
Date Initiated by FirmMay 05, 2025
Date PostedJune 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1901-2025
Recall Event ID 96824
510(K)NumberK223405 
Product Classification Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
ProductAccess Testosterone assay, Catalog Number 33560
Code Information UDI-DI: 15099590231347; Serial Number: 538081
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		Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
FDA Determined
Cause 2		Equipment maintenance
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 4/23/25 was sent to customers. ACTION: Discontinue using and discard all remaining Access Testosterone reagent packs from the lot listed above. Beckman Coulter recommends performing a retrospective review on patient results generated with the Access Testosterone lot listed above and assessing the need for retesting. Contact your local Beckman Coulter representative for replacement product requests. Beckman Coulter is no longer distributing the affected Access Testosterone reagent pack lot number and has corrected the manufacturing issue that led to cross-contamination. 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 If you need replacement product: o Complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR o Call Client Services at (800) 526-3821
Quantity in Commerce70 units
DistributionUS State: FL. UAE, Vietnam
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 = CDZ
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