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/ 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 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
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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.
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PMA Database |
PMAs with Product Code = LOM and Original Applicant = Bio-Rad Laboratories, Inc.
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