Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60
FDA device recall Z-0801-03 · posted 2003-05-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD
- Reason for recall
- Particulate matter in the microparticle component.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOM
- Quantity affected
- 289 kits
- Distribution
- Canada, Germany and Japan
- Date initiated
- 2003-04-07
- Date posted
- 2003-05-09
- Date terminated
- 2003-08-19
- Location
- Abbott Park, IL
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