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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 Systemsee related information
Date Initiated by FirmMarch 20, 2019
Create DateMay 20, 2019
Recall Status1 Terminated 3 on December 08, 2020
Recall NumberZ-1364-2019
Recall Event ID 82561
510(K)NumberK182063 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductVITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
Code Information Serial Number 76000108 thru current.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
FDA Determined
Cause 2		Software design
ActionOrtho Clinical Diagnostics issued on 20 March 2019, a customer letter via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) customers who were shipped affected VITROS XT 7600 Systems. Software Version 3.4.2 (MOD 4) will be provided for download or DVD format. Contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce85 units: US=19;OUS=66
DistributionWorldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines
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 = JJE
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