ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Par
FDA device recall Z-0781-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.
- Action taken
- Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIG
- Quantity affected
- 1,987 kits
- Distribution
- Canada, Australia, Germany and Japan
- Date initiated
- 2004-03-23
- Date posted
- 2004-07-20
- Date terminated
- 2005-04-26
- Location
- Abbott Park, IL
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