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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack

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  Class 3 Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack see related information
Date Initiated by Firm May 09, 2016
Create Date July 08, 2016
Recall Status1 Terminated 3 on June 08, 2018
Recall Number Z-2145-2016
Recall Event ID 74346
510(K)Number K983031  
Product Classification Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
Product VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators.

For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
Code Information Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS
Bridgend United Kingdom
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter (Ref. CL2016-098) dated 5/9/2016, via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected product. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue distributing and discard the affected lots; complete and return the Confirmation of Receipt form by May 18, 2016 via Fax to 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: ConfirmationAdmin@its.jnj.com, and forward this notification if you have distributed these systems outside of your facility. If you have any questions, contact Customer Technical Services at 1-800-421-3311.
Quantity in Commerce US: Lot 6471 - 282, Lot 6480 - 344
Distribution US Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = LOJ and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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