Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
This recall has been terminated (originally issued May 9, 2003).
- Company
- Abbott Laboratories Hpd/Add
- Recall Initiated
- April 7, 2003
- Posted
- May 9, 2003
- Terminated
- August 19, 2003
- Recall Number
- Z-0801-03
- Quantity
- 289 kits
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Particulate matter in the microparticle component.
Distribution
Canada, Germany and Japan
Lot / Code Info
List 7C18-25, lot 95305M200
Root Cause
Other
Action Taken
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.
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