Recall Z-1386-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Access 2 Immunoassay Analyzer, Catalog Number 81600N
| Date | Mar 17, 2025 (initiated Feb 5, 2025) |
| Status | Open, Classified |
| Reason | Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 1/31/25 was sent to customers. If the error occurs: 1. Confirm the system is in the Ready or Not Ready mode. 2. Go to the Initialize System window. To get to this window from the Main Menu, select Diagnostics F7 to display the Diagnostics menu, then select Initialize System F1. The Initialize System window is displayed with a confirmation message. 3. Select Yes F1 to initialize the instrument. Contact your Beckman Coulter representative if your laboratory has experienced sample carousel motion errors that are not resolved by initializ |
| Quantity | 873 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121214 | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM Beckman Coulter, Inc., Jun 14, 2013 |