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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measurement.

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  Class 3 Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measurement. see related information
Date Initiated by Firm January 11, 2018
Date Posted April 10, 2018
Recall Status1 Terminated 3 on September 08, 2020
Recall Number Z-1322-2018
Recall Event ID 79508
510(K)Number K083173  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product VITROS Immunodiagnostic Products TSH Reagent Pack
Code Information Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017.
Recalling Firm/
Clinical Diagnostic Systems
601 Lee Rd Ny
Rochester NY 14652-0001
Manufacturer Reason
for Recall
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.
Quantity in Commerce Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)
Distribution Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
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