FDA Device

Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

Hazard

Particulate matter in the microparticle component.

What You Should Do

Remedy

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.

Products

Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD
UPC
List 7C18-25, lot 95305M200

Units Affected

289 kits