ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, A
FDA device recall Z-1392-05 · posted 2005-08-24 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories MPG
- Reason for recall
- False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.
- Action taken
- Abbott notified their affiliates in all four countries via e-mail on 3/16/05. 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 positve results, and were requested to destroy any remaining inventory of the affected lots.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 7607 kits
- Distribution
- Canada, Germany, Hong Kong and Australia
- Date initiated
- 2005-03-16
- Date posted
- 2005-08-24
- Date terminated
- 2006-05-25
- 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 HCG COMBO WITH OBC (K965116) | Abbott Laboratories | 1997-02-20 |