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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 4600 Chemistry System

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 Class 2 Device Recall VITROS 4600 Chemistry Systemsee related information
Date Initiated by FirmDecember 21, 2015
Date PostedMarch 08, 2016
Recall Status1 Terminated 3 on May 30, 2018
Recall NumberZ-1073-2016
Recall Event ID 72979
510(K)NumberK031924 K063144 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductVITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Code Information Software Version 3.2 and below; Serial Numbers J46000001 - 46000678
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactMs. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
FDA Determined
Cause 2
Error in labeling
ActionOrtho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.
Quantity in CommerceUS = 163; Foreign = 286
DistributionWorldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
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
510(K)s with Product Code = JJE
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