Date Initiated by Firm |
December 15, 2005 |
Date Posted |
January 06, 2006 |
Recall Status1 |
Terminated 3 on August 07, 2007 |
Recall Number |
Z-0327-06 |
Recall Event ID |
34238 |
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Product Classification |
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - Product Code LOM
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Product |
Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit. |
Code Information |
Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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For Additional Information Contact |
Judy M. Strzepek 908-218-8524
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Manufacturer Reason for Recall |
Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.
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FDA Determined Cause 2 |
Other |
Action |
Letters sent overnight mail on 12/15/2005. Customers instructed to discontinue use and discard remaining inventory. In a separate Q&A sheet, Ortho recommends that previously reported results be reviewed. |
Quantity in Commerce |
436 kits |
Distribution |
Nationwide distribution to end users (medical facilities, testing labs and public health agencies). One J&J foreign affiliate in Puerto Rico with sub-distribution in the Caribbean. |
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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