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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 System see related information
Date Initiated by Firm February 07, 2013
Date Posted April 13, 2013
Recall Status1 Open3, Classified
Recall Number Z-1107-2013
Recall Event ID 64577
510(K)Number K031924  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445.

Intended for use in the measurement of a variety of chemistry analytes.
Code Information Serial Numbers 46000108 through 46000217
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
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
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: 58 units, Foreign: 103 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 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS
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