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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 Laboratoriessee related information
Date Initiated by FirmNovember 06, 2003
Date PostedJanuary 14, 2004
Recall Status1 Terminated 3 on January 27, 2004
Recall NumberZ-0348-04
Recall Event ID 28013
510(K)NumberK023857 
Product Classification Antigen, Galactomannan, Aspergillus Spp. - Product Code NOM
ProductPlatelia Aspergillus EIA
Code Information Lot number: 3F0001  Exp. 2004-05-15
FEI Number 3008272466
Recalling Firm/
Manufacturer		 Bio Rad Laboratories, Inc.
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information Contact
425-881-8300
Manufacturer Reason
for Recall		Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
FDA Determined
Cause 2		Other
ActionCustomers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003.
Quantity in Commerce147 kits
DistributionThe firm distributed to hospitals and diagnostic laboratories nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NOM
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