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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS AntiHBS Reagent Pack

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  Class 3 Device Recall VITROS AntiHBS Reagent Pack see related information
Date Initiated by Firm November 01, 2012
Date Posted April 23, 2013
Recall Status1 Terminated 3 on March 30, 2017
Recall Number Z-1161-2013
Recall Event ID 64739
PMA Number P000014/SO25 
Product Classification Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
Product VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs

For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.

Code Information Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Jennifer Paine
Manufacturer Reason
for Recall
Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
FDA Determined
Cause 2
Under Investigation by firm
Action Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated November 1, 2012, to all affected customers via USPS. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue and discard any remaining recalled lots of VITROS Anti-HBS Reagent Packs. Foreign affiliates were informed by email on November 1, 2012, of the issue and instructed to notify their consignees of the issue and actions . On March 22, 2013, OCD sent customer letters via FedEX overnight and/or via USPS to US consignees for two additional lots of product being recalled. The letter provided similar recall instructions as the initial notification. Ortho Clinical Diagnostics has requested that their clients discontinue and discard any remaining inventory of VITROS Anti-HBS Reagent Packs subject to this recall. OCD has also requested that recall product recipients also complete a Confirmation of Receipt and return that document to OCD, fax to: 1-888-557-3759 or 585-453-4110. We apologize for any inconvenience this may cause your laboratory. If you have technical questions please contact Customer Technical Services at 1-800-421-3311. If you have questions about your replacement order, please call our Customer Service Center at 1-800-828-6316.
Quantity in Commerce 1464 units
Distribution Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
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.