ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha h
FDA device recall Z-1399-05 · posted 2005-08-24 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories MPG
- Reason for recall
- False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.
- Action taken
- Abbott notified their affiliates in all eight countries via e-mail on 8/7/05. Each Abbott international country organization is responsible for translating the customer letter, contacting customers and determining the method of effectiveness checks based on their country requirements. The recall letters inform the accounts of the false positive results, and were requested to return any remaining inventory of the affected lots to Abbott in Germany.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 3049 kits
- Distribution
- This product is not distributed in the U.S. It was distributed internationally to Canada, Germany, Honduras, Nicaragua, the Bahamas, the Philippines (via Singapore), New Zealand, and Uruguay
- Date initiated
- 2005-08-07
- Date posted
- 2005-08-24
- Date terminated
- 2006-03-27
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT TESTPACK PLUS TM HCG-COMBO (K903219) | Abbott Laboratories | 1990-09-25 |