FDA Recall
Terminated
Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Recall: Z-0801-03
·
Initiated April 7, 2003
Recall
- Recall Number
- Z-0801-03
- Event Number
- 25957
- Firm
- Abbott Laboratories HPD/ADD
- FEI Number
- 1415939
- Product Code
- LOM--
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 7, 2003
- Posted
- May 9, 2003
- Terminated
- August 19, 2003
- Address
- 100/200 Abbott Park Road, Abbott Park, IL, 60064
Description
Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Reason
Particulate matter in the microparticle component.
Action
Abbott affiliates in Canada, Germany and Japan were faxed copies of the recall letter on 4/7/03 for translation where needed and dissemination to their accounts receivin the suspect lot. The end users were advised of the mold-microparticle aggregation and instructed to discontinue use and destroy any of the lot remaining.
Distribution
Canada, Germany and Japan
Quantity
289 kits