| Date Initiated by Firm |
October 19, 2018 |
| Create Date |
December 20, 2018 |
| Recall Status1 |
Terminated 3 on January 24, 2022 |
| Recall Number |
Z-0650-2019 |
| Recall Event ID |
81563 |
| 510(K)Number |
K081543
|
| Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
| Product |
VITROS 5600 Integrated System, Version 3.3.1 & below
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. |
| Code Information |
1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished) UDI 10758750007110 Serial Numbers: 56000427 56000750 56001012 56001535 56001152 56001641 56000327 56000585 56001437 56000786 56000255 56001235 56000792 56001062 56000308 56001184 56000315 56000458 56001570 56000825 56000661 56000261 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56001264 56000646 56000655 56001027 56001128 56000796 56000890 56000928 56001359 56001851 56000533 56001111 56001689 |
Recalling Firm/
Manufacturer |
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
|
| For Additional Information Contact |
Ortho 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 |
| Action |
On 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 Commerce |
2413 |
| Distribution |
US Nationwide Distribution |
| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.
|
