Recall Z-1392-05 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Abbott Laboratories MPG
ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA
| Date | Aug 24, 2005 (initiated Mar 16, 2005) |
| Status | Terminated |
| Reason | False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control. |
| Root cause | Other |
| Action | 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. |
| Quantity | 7607 kits |
| Distribution | Canada, Germany, Hong Kong and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965116 | ABBOTT TESTPACK PLUS HCG COMBO WITH OBC Abbott Laboratories, Feb 20, 1997 |