ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which u
FDA device recall Z-0010-06 · posted 2005-10-06 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Software deficiency causing potential shift in absorbance readings for test results.
- Action taken
- Firm sent device correction letter to consignees on 9/14/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1,107 units
- Distribution
- Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapo
- Date initiated
- 2005-09-14
- Date posted
- 2005-10-06
- Date terminated
- 2007-09-25
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |