Class 3 Device Recall MONOLISA

• Date Initiated by Firm: September 05, 2007
• Date Posted: October 31, 2007
• Recall Status: Terminated on November 15, 2007
• Recall Number: Z-0065-2008
• Recall Event ID: 44881
• PMA Number: P060034
• Product Classification: Anti-HBc IGM EIA kit, - Product Code LOM
• Product: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
• Code Information: Lot 131BHH, Catalog # 26174
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories; 6565 185th Ave NE; Redmond WA 98052-5039
• For Additional Information Contact: Scott Dennis; 425-498-1741
• Manufacturer Reason for Recall: Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
• FDA Determined Cause: Error in labeling
• Action: On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.
• Quantity in Commerce: 46
• Distribution: Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.
• 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.

• PMA Database: PMAs with Product Code = LOM