FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Access Testosterone assay, Catalog Number 33560
- Recall number
- Z-1901-2025
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Access Testosterone assay, Catalog Number 33560
- Status
- Open, Classified
- Initiated
- 2025-05-05
- Posted
- 2025-06-02
- Terminated
- not on file
- Reason
- 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
- Equipment maintenance
- Action
- 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
- Quantity
- 70 units
- Distribution
- US State: FL. UAE, Vietnam
- Lot, serial or model codes
- UDI-DI: 15099590231347; Serial Number: 538081
- 510(k) numbers
- ["K223405"]
- PMA numbers
- not on file
- Product code
- CDZ
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28