Class 2 Device Recall BioRad Laboratories

• Date Initiated by Firm: November 06, 2003
• Date Posted: January 14, 2004
• Recall Status: Terminated 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/ 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: Other
• 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