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U.S. Department of Health and Human Services

Class 2 Device Recall Vitros 5,1

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 Class 2 Device Recall Vitros 5,1see related information
Date Initiated by FirmOctober 19, 2018
Create DateDecember 20, 2018
Recall Status1 Terminated 3 on January 24, 2022
Recall NumberZ-0651-2019
Recall Event ID 81563
510(K)NumberK063144 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductVITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Code Information Product code: 6801375 UDI: 10758750001132 Serial Numbers: J34000132- J34002322  
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactOrtho Care Technical Solutions
800-421-3311
Manufacturer Reason
for Recall		Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionOn October 19, 2018, Ortho Clinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" notices via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers to inform them of the issue and actions to take to prevent occurrence of the anomaly. On November 19, 2018 Ortho Clinical Diagnostics re-issued correction notices to customers pertaining to the 5,1 FS system (CL2018-194_5,1FS). Customers may continue using their VITROS Systems and have been informed that the software issue will be mitigated with the next version of software. The expected dates of these software versions are included in the communication. Foreign affiliates were informed by email approximately on 21 October 2018 of the issue and instructed to notify their consignees of the issue and required actions to prevent the occurrence of the anomaly. Please refer to the Customer letter (Ref. CL2018-194_51FS, CL2018-194_3600, CL2018-194_4600, and CL2018-194_5600) for specific details on Required Actions by User. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce1105
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
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