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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack

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  Class 3 Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack see related information
Date Initiated by Firm July 28, 2016
Create Date August 17, 2016
Recall Status1 Terminated 3 on June 11, 2018
Recall Number Z-2580-2016
Recall Event ID 74828
510(K)Number K083173  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK
For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Code Information Lot 5040 (Expiry date 19 Dec 2016)
Recalling Firm/
Bridgend United Kingdom
For Additional Information Contact Ms. Jennifer Paine
Manufacturer Reason
for Recall
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.
FDA Determined
Cause 2
Under Investigation by firm
Action Ortho Clinical Diagnostics sent an Important Product Correction Notification letter on July 28, 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 VITROS Immunodiagnostic Product TSH, Lot 5040 to inform them of the issue and the required actions. Instructions were provided to customers. Customers with questions were instructed to contact Ortho Care" Technical Solutions Center at 1-800-421-3311. Foreign affiliates were informed by e-mail on July 28, 2016, of the issue and instructed to notify their consignees of the issue and the required actions. For questions regarding this recall call 908-218-8776.
Quantity in Commerce Domestic: 2883, Foreign: 1261
Distribution Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
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 = JLW and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS