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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 Recall
VITROS Immunodiagnostics Products HBsAg Reagent Pack
see related information
Date Posted April 14, 2007
Recall Status1 Open
Recall Number Z-0747-2007
Recall Event ID 37528
Premarket Approval
PMA Number
P000044
Product Classification Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - 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
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.
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 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 Applicant = ORTHO-CLINICAL DIAGNOSTICS, INC.
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