Recall Z-0023-2007 ยท JIS Calibrator, Primary
Abbott Diagnostic International, Ltd.
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
| Date | Oct 12, 2006 (initiated Sep 7, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Baha |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935612 | AXSYM FOLLICLE STIMULATING HORMONE (FSH) Abbott Laboratories, Jun 21, 1994 |