Date Initiated by Firm |
October 10, 2023 |
Date Posted |
December 13, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0545-2024 |
Recall Event ID |
93366 |
510(K)Number |
K081543
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0 |
Code Information |
Product Code: 6802413,
UDI-DI: 10758750002740;
Product Code: 6802915,
UDI-DI: 10758750007110;
Serial Numbers: J56000116 J56003330 J56000102 J56001793
J56000317 J56003334 J56000161 J56001826
J56001292 J56003342 J56000246 J56001844
J56001523 J56003356 J56000252 J56001925
J56001629 J56003369 J56000418 J56001929
J56001885 J56003373 J56000425 J56001944
J56001886 J56003377 J56000468 J56001979
J56001910 J56003416 J56000512 J56002028
J56002041 J56003433 J56000533 J56002099
J56002064 J56003477 J56000665 J56002116
J56002159 J56003478 J56000671 J56002218
J56002196 J56003484 J56000680 J56002258
J56002198 J56003496 J56000719 J56002300
J56002199 J56003541 J56000831 J56002410
J56002201 J56003570 J56000836 J56002410
J56002249 J56003578 J56000910 J56002460
J56002301 J56003581 J56000929 j56002615
J56002308 J56003583 J56000972 J56002625
J56002358 J56003632 J56000980 J56002625
J56002461 J56003646 J56000993 J56002637
J56002463 J56003655 J56000994 J56002821
J56002466 J56003668 J56001015 J56002862
J56002474 J56003669 J56001097 J56002913
J56002477 J56003670 J56001111 J56002913
J56002500 J56003672 J56001140 J56002966
J56002591 J56003725 J56001208 J56003162
J56002603 J56003730 J56001260 J56003179
J56002607 J56003752 J56001320 J56003260
J56002608 J56003759 J56001355 J56003401
J56002698 J56003774 J56001378 J56003451
J56002703 J56003911 J56001389 J56003508
J56002704 J56003919 J56001469 J56004078
J56002719 J56004068 J56001509 J56004082
J56002722 J56004137 J56001631 J56004308
J56002769 J56004174 J56001689 J56004309
J56002874 J56004240 J56001731 J56004355
J56002895 J56004325 J56001765 J56004414
J56002935 J56004326 J56001780 J56004531
J56002955 J56004485
J56003035 J56004498
J56003037 J56004506
J56003045 J56004512
J56003076 J56004549
J56003113 J56004551
J56003190 J56004571
J56003199 J56004577
J56003220 J56004587
J56003287 J56004589
J56003299 J56004604
J56003317 J56004606
|
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr Rochester NY 14626-5101
|
For Additional Information Contact |
Joe Falvo 585-453-3452
|
Manufacturer Reason for Recall |
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
An URGENT PRODUCT CORRECTION NOTIFICATION letter dated 10/10/23 was sent to customers.
REQUIRED ACTIONS
" Review the Customer Actions for the Condition Codes described in this notification.
" Acknowledge your understanding of this notification by completing the enclosed Confirmation of Receipt form no later than October 18, 2023.
" Save this notification with your User Documentation or post this notification by each VITROS 3600/4600/5600/XT 3400/XT 7600 System until this issue is resolved.
" If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization (Previously Ortho Care).
Resolution
QuidelOrtho is investigating root cause and will communicate again after root cause has been determined. A software update to address this issue is currently in development.
Contact Information
We apologize for any inconvenience this may cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311. |
Quantity in Commerce |
176 units |
Distribution |
US Nationwide. Global Distribution. |
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 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.
|