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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products AntiHBs Calibrators & AntiHBs Reagent Packs

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 Class 2 Recall
VITROS Immunodiagnostic Products AntiHBs Calibrators & AntiHBs Reagent Packs
see related information
Date Posted December 20, 2013
Recall Status1 Open
Recall Number Z-0557-2014
Recall Event ID 66900
Premarket Approval
PMA Numbers
P000014 P000014/S025
Product Classification Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - Product Code LOM
Product VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Code Information Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester, New York 14626-5101
Manufacturer Reason
for Recall
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action On October 25, 2013, Ortho Clinical Diagnostics issued product correction notifications to their US customers via US Postal Service Priority Mail and email notices to their foreign affiliates informing them of the recall. Ortho Clinical Diagnostics advised their customers to review previously reported results between > 12 and <30 mIU/mL and consult the Laboratory Medical Director. Customers were instructed to utilize alternative methods for anti-HBs testing. Customers are advised to seek alternative methods for anti-HBs testing. For additional information, please contact the OCD Customer Technical Service representative at 1-800-421-3311.
Quantity in Commerce 1,920 kits
Distribution Nationwide distribution - all states.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LOM and Applicant = ORTHO-CLINICAL DIAGNOSTICS, INC.
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