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U.S. Department of Health and Human Services

Class 3 Device Recall MONOLISA

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  Class 3 Device Recall MONOLISA see related information
Date Initiated by Firm September 05, 2007
Date Posted October 31, 2007
Recall Status1 Terminated 3 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/
Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact Scott Dennis
Manufacturer Reason
for Recall
Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
FDA Determined
Cause 2
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 and Original Applicant = Bio-Rad Laboratories, Inc.