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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 FirmJanuary 11, 2018
Date PostedApril 10, 2018
Recall Status1 Terminated 3 on September 08, 2020
Recall NumberZ-1322-2018
Recall Event ID 79508
510(K)NumberK083173 
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
ProductVITROS 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.
FEI Number 3003939841
Recalling Firm/
Manufacturer		 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
ActionDistributors 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 CommerceLot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)
DistributionDistributors 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 CycleTPLC 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) Database510(K)s with Product Code = JLW
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