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U.S. Department of Health and Human Services

Class 2 Device Recall BioRad Laboratories

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  Class 2 Device Recall BioRad Laboratories see related information
Date Initiated by Firm November 06, 2003
Date Posted January 14, 2004
Recall Status1 Terminated 3 on January 27, 2004
Recall Number Z-0348-04
Recall Event ID 28013
510(K)Number K023857  
Product Classification Antigen, Galactomannan, Aspergillus Spp. - Product Code NOM
Product Platelia Aspergillus EIA
Code Information Lot number: 3F0001  Exp. 2004-05-15
Recalling Firm/
Bio Rad Laboratories, Inc.
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information Contact
Manufacturer Reason
for Recall
Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
FDA Determined
Cause 2
Action Customers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003.
Quantity in Commerce 147 kits
Distribution The firm distributed to hospitals and diagnostic laboratories nationwide.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = NOM and Original Applicant = BIO-RAD