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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 Device Recall VITROS Immunodiagnostic Products AntiHBs Calibrators & AntiHBs Reagent Packs see related information
Date Initiated by Firm October 25, 2013
Date Posted December 20, 2013
Recall Status1 Terminated 3 on May 18, 2018
Recall Number Z-0557-2014
Recall Event ID 66900
PMA Number P000014 P000014S025 
Product Classification Hepatitis b (b core, be antigen, be antibody, be core igm) test - 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 NY 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
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 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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