Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.
FDA device recall Z-0619-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Spring failure, design defect in component.
- Action taken
- A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment)
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2418
- Distribution
- Product has been distributed in US from 8/92 to present. All these units are affected.
- Date initiated
- 2003-01-27
- Date posted
- 2003-03-06
- Date terminated
- 2003-10-08
- 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 |
|---|---|---|
| ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS (K922823) | Bio-Rad Laboratories, Inc. | 1992-08-05 |