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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 4600 Chemistry System/ VITROS 4600 Chemistry System Refurbished

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  Class 2 Device Recall VITROS 4600 Chemistry System/ VITROS 4600 Chemistry System Refurbished see related information
Date Initiated by Firm July 08, 2019
Create Date August 06, 2019
Recall Status1 Open3, Classified
Recall Number Z-2182-2019
Recall Event ID 83322
510(K)Number K063144  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS 4600 Chemistry System, clinical chemistry analyzer
Code Information product code: 6900440 UDI: 10758750033201 Affected software : Version 3.3.2 or above  
Recalling Firm/
Manufacturer
Ortho Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Mr. Joe Falvo
585-453-3452
Manufacturer Reason
for Recall
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
FDA Determined
Cause 2
Software design
Action Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your facility. For the VITROS 4600,5600 and 5,1 FS chemistry System: If your system is configured with User Modified parameters, choose an option provided in the Interim Resolutions section listed above. Install ADD DRV 6040 or above upon availability. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification either by each system that processes VITROS Calibrator Kit 32 or with your user documentation until DRV 6040 or above is installed on your system(s). Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 9
Distribution Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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, Inc.
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