Recall Z-1901-2025 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Beckman Coulter, Inc.
Access Testosterone assay, Catalog Number 33560
| Date | Jun 2, 2025 (initiated May 5, 2025) |
| Status | Open, Classified |
| 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 |
| Quantity | 70 units |
| Distribution | US State: FL. UAE, Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223405 | Access Testosterone Beckman Coulter, Inc., Jan 13, 2023 |