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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostics Products HBsAg Reagent Pack

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  Class 2 Device Recall VITROS Immunodiagnostics Products HBsAg Reagent Pack see related information
Date Initiated by Firm February 01, 2007
Date Posted April 14, 2007
Recall Status1 Terminated 3 on August 03, 2012
Recall Number Z-0747-2007
Recall Event ID 37528
PMA Number P000044 
Product Classification HBsAg Reagent Pack - Product Code LOM
Product VITROS¿ Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.
Code Information Lots 6000 and 6030 thru 6120
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
Forest Farm Estate, Whitechurch
Cardiff United Kingdom
For Additional Information Contact Ms. Judy M. Strzepek
908-218-8524
Manufacturer Reason
for Recall		 Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.
FDA Determined
Cause 2		 Other
Action On 2/01/07, all US end-user consignees who received the VITROS HBsAg Reagent Packs, were informed of this issue by Federal Express overnight letter, and informed that they may continue to use their current lot of VITROS HBsAg Reagent Pack providing that they followed the instructions in the letter. INSTRUCTIONS: Please do the following if you choose to continue using sodium citrate and/or EDTA plasma collection tubes: - Do not freeze samples collected in sodium citrate or EDTA plasma collection tubes prior to processing the assay. - Process samples collected into sodium citrate plasma tubes within 12 hrs. of collection. -Continue to perform supplemental testing to confirm all HBsAg results that repeat as 'Borderline' or 'Reactive', as directed in the Package Insert. - Complete and return the attached Confirmation of Receipt Form upon receipt of this notification. - Forward the information in this notification if you have distributed the product outside your facility
Quantity in Commerce Cat. #6801322 (1 Reagent Pack box per sales unit): 11,761 units; Cat. #6802450 (5 Reagent Pack boxes per sales unit): 4125 units
Distribution Worldwide Distribution --- USA including Puerto Rico and countries of Tortola (British Virgin Islands) and Anguilla.
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 = Ortho-Clinical Diagnostics, Inc.
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