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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS XT 7600 Integrated System

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  Class 2 Device Recall VITROS XT 7600 Integrated System see related information
Date Initiated by Firm March 11, 2019
Create Date April 25, 2019
Recall Status1 Terminated 3 on December 07, 2020
Recall Number Z-1222-2019
Recall Event ID 82366
510(K)Number K182063  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658

Product Usage:
The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents
Code Information Systems Running Software Version 3.4 & 3.4.1
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		 One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
FDA Determined
Cause 2		 Software design
Action Urgent Product Correction Notification letters dated 3/11/19 were sent to customers.
Quantity in Commerce 80
Distribution Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom
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 = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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