—#213728

Product

Access Testosterone assay, Catalog Number 33560

FDA product code: CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K223405
Affected lot / code info: UDI-DI: 15099590231347; Serial Number: 538081

Why it was recalled

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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

An 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

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: US State: FL. UAE, Vietnam

Timeline

Recall initiated: 2025-05-05
Posted by FDA: 2025-06-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.