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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 5600 Integrated System

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  Class 2 Device Recall VITROS 5600 Integrated System see related information
Date Initiated by Firm August 15, 2018
Create Date October 05, 2018
Recall Status1 Terminated 3 on January 10, 2022
Recall Number Z-0079-2019
Recall Event ID 80959
510(K)Number K081543  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,
Catalog Number: 6802413
Code Information Serial Numbers : J56000024 through J56003300
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
FDA Determined
Cause 2		 Software design
Action ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent 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¿ 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director.
Quantity in Commerce U.S.= 1255 ex-U.S.= 1504
Distribution Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
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, Inc.
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