Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNC
FDA device recall Z-1183-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.
- Action taken
- Beckman Coulter mailed a Product Corrective Action (PCA) letter on October 17, 2007 to all Access and Access 2 lmmunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System customers. The customers were informed that during manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering. The letter referenced a proactive initiative to inspect the power supply sled assemblies on all instruments referenced. A response form was included.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 3055 instruments in the US; 192 instruments in Canada
- Distribution
- Nationwide Distribution and Canada
- Date initiated
- 2007-10-17
- Date posted
- 2008-08-20
- Date terminated
- 2012-04-27
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (K060256) | Beckman Coulter, Inc. | 2006-02-27 |
| SYNCHRON LX I 725 CLINICAL SYSTEM (K023049) | Beckman Coulter, Inc. | 2002-10-04 |
| ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS (K922823) | Bio-Rad Laboratories, Inc. | 1992-08-05 |