Access Testosterone assay, Catalog Number 33560 recallZ-1901-2025 · Beckman Coulter, Inc. · initiated May 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Equipment maintenance
What the company is doing
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 [email protected] or fax to (866) 294-7850 OR o Call Client Services at (800) 526-3821
Recall details
- Recall number
- Z-1901-2025
- Status
- Open, Classified
- Initiated by the company
- May 5, 2025
- Posted by the FDA
- Jun 2, 2025
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 70 units
- Product code
- CDZ
- FDA submissions
- K223405
- Distribution
- US State: FL. UAE, Vietnam
Product description
Access Testosterone assay, Catalog Number 33560
Code information (models, lots, serial numbers)
UDI-DI: 15099590231347; Serial Number: 538081
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Access Testosterone 33560Beckman Coulter, Inc. · Radioimmunoassay, Testosterones And Dihydrotestosterone1 recall16 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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