Recall Z-1399-05 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Abbott Laboratories MPG
ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 USA
| Date | Aug 24, 2005 (initiated Aug 7, 2005) |
| Status | Terminated |
| Reason | False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903219 | ABBOTT TESTPACK PLUS TM HCG-COMBO Abbott Laboratories, Sep 25, 1990 |