Access Progesterone Assay, Part number 33550.
FDA device recall Z-0494-03 · posted 2003-01-30 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Primary tube sampling issue may cause false low results.
- Action taken
- Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- JLS
- Quantity affected
- 6,655
- Distribution
- USA and Canada.
- Date initiated
- 2002-12-06
- Date posted
- 2003-01-30
- Date terminated
- 2003-07-26
- 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 PROGESTERONE ASSAY (K955769) | Bio-Rad Laboratories, Inc. | 1996-02-05 |