MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
FDA device recall Z-0053-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- bioMerieux
- Reason for recall
- Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
- Action taken
- Consignees were notified by letter on 8/20/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJA
- Quantity affected
- 1165 units
- Distribution
- Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK
- Date initiated
- 2004-08-20
- Date posted
- 2004-10-28
- Date terminated
- 2005-06-09
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIBRI QUIK (K802117) | General Diagnostics | 1980-09-26 |