| Class 2 Device Recall VITROS 5,1 FS Chemistry System/ VITROS 5,1 FS Chemistry System Refurbished | |
Date Initiated by Firm | July 08, 2019 |
Create Date | August 06, 2019 |
Recall Status1 |
Terminated 3 on October 19, 2023 |
Recall Number | Z-2184-2019 |
Recall Event ID |
83322 |
510(K)Number | K063144 |
Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
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Product | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer |
Code Information |
product code:6801890 UDI: 10758750001644 Affected software : Version 3.1 or above |
Recalling Firm/ Manufacturer |
Ortho Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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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 | 55 |
Distribution | Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JIX
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