Recall Z-1048-04 ยท GTZ Antisera, All Groups, Streptococcus Spp.
Abbott Laboratories HPD/ADD/GPRD
ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
| Date | Jul 20, 2004 (initiated Jun 11, 2004) |
| Status | Terminated |
| Reason | False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control. |
| Root cause | Other |
| Action | A Device Recall Letter was sent to customers that received the affected product lots on 6/11/04 via Federal Express Priority. The accounts were informed of the false positive readings, and were requested to destroy any affected inventory of the recalled lots. |
| Quantity | 75,368 kits |
| Distribution | The product was not distributed in the U.S. The product was distributed internationally through Abbott affiliates in Argentina, Korea, the United kingdom, Japan, Singapore, the Dominican Republic, Canada, Hong Kong, Chile and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971522 | ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II Abbott Laboratories, Mar 3, 1998 |