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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Architect AntiHBs Reagent

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  Class 2 Device Recall Abbott Architect AntiHBs Reagent see related information
Date Initiated by Firm April 07, 2003
Date Posted May 09, 2003
Recall Status1 Terminated 3 on August 19, 2003
Recall Number Z-0801-03
Recall Event ID 25957
Product Classification unknown device name - Product Code LOM--
Product Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Code Information List 7C18-25, lot 95305M200
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD
100/200 Abbott Park Road
Abbott Park IL 60064
Manufacturer Reason
for Recall		 Particulate matter in the microparticle component.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 289 kits
Distribution Canada, Germany and Japan
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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