ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of
FDA device recall Z-0860-06 · posted 2006-05-11 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories MPG
- Reason for recall
- The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument.
- Action taken
- Abbott affiliates in Canada, Germany and Australia were e-mailed copies of the recall letter on 3/8/06 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised that the 30-day onboard storage information is not included in the barcode for the two lots. As a result the ARCHITECT system software is unable to track how long the reagent kit has been stored onboard. The accounts were instructed to manually track the onboard storage time for the two lots, and discard the kits after 30 days of onboard storage.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIG
- Quantity affected
- 135 kits
- Distribution
- Canada, Germany and Australia
- Date initiated
- 2006-03-08
- Date posted
- 2006-05-11
- Date terminated
- 2006-07-31
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT B12 (K984108) | Abbott Laboratories | 1999-02-03 |