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U.S. Department of Health and Human Services

Class 1 Device Recall

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 Class 1 Device Recallsee related information
Date Initiated by FirmDecember 15, 2005
Date PostedJanuary 06, 2006
Recall Status1 Terminated 3 on August 07, 2007
Recall NumberZ-0327-06
Recall Event ID 34238
Product Classification Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) - Product Code LOM
ProductVitros 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
FEI Number 1000136573
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactJudy M. Strzepek
908-218-8524
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'.
FDA Determined
Cause 2		Other
ActionLetters 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 Commerce436 kits
DistributionNationwide 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 CycleTPLC 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.
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