ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit
FDA device recall Z-1048-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GTZ
- Quantity affected
- 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, Can
- Date initiated
- 2004-06-11
- Date posted
- 2004-07-20
- Date terminated
- 2004-10-05
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (K971522) | Abbott Laboratories | 1998-03-03 |