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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 Recall
VITROS 5600 Integrated System
see related information
Date Posted June 09, 2014
Recall Status1 Open
Recall Number Z-1735-2014
Recall Event ID 68271
Premarket Notification
510(K) Number
K081543 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Code Information Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester, New York 14626-5101
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected
Action Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without an MW code are acceptable. -- Review their current Laboratory Information System (LIS) configuration to determine if changes are required in order to restrict reporting of results with an MW code. Customers with questions should contact Customer Technical Services at 1-800-421-3311. --- Foreign affiliates were informed of the issue by e-mail on 4/10/2014 and instructed to notify their consignees of the issue and actions.
Quantity in Commerce Domestic - 835 units, Foreign - 921 units
Distribution Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 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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