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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 April 13, 2013
Recall Status1 Open
Recall Number Z-1108-2013
Recall Event ID 64577
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 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Code Information Serial Numbers 56000118 through 56001583
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester, New York 14626-5101
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall
Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS® System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.
Quantity in Commerce USA: 775 units, Foreign: 800 units
Distribution Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of 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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS, INC.
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