Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
FDA device recall Z-0023-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Reason for recall
- Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
- Action taken
- The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIS
- Quantity affected
- 797
- Distribution
- Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapor
- Date initiated
- 2006-09-07
- Date posted
- 2006-10-12
- Date terminated
- 2011-09-09
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM FOLLICLE STIMULATING HORMONE (FSH) (K935612) | Abbott Laboratories | 1994-06-21 |