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VITROS recallZ-0544-2024 · Ortho-Clinical Diagnostics, Inc. · initiated Oct 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0544-2024
Status
Open, Classified
Initiated by the company
Oct 10, 2023
Posted by the FDA
Dec 13, 2023
Recalling firm
Ortho-Clinical Diagnostics, Inc.
Quantity
51 units
Product code
JJE
FDA submissions
K031924
Distribution
US Nationwide. Global Distribution.

Product description

VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

Code information (models, lots, serial numbers)

Product Code: 6802445, UDI-DI: 10758750012343; Product Code: 6900440, UDI-DI: 10758750033201; Serial Numbers: J46000208 J46000019 J46000861 J46000209 J46000020 J46000910 J46000240 J46000150 J46000983 J46000497 J46000162 J46001029 J46000864 J46000247 J46001041 J46000865 J46000296 J46001042 J46000898 J46000393 J46001119 J46001030 J46000410 J46001210 J46001064 J46000478 J46001217 J46001125 J46000499 J46001289 J46001132 J46000531 J46001541 J46001252 J46000564 J46001565 J46001293 J46000617 J46001609 J46001462 J46000772 J46001629 J46001703 J46000788 J46001639 J46001704 J46000800 J46001645 J46000820 J46001680 J46000859

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93366).

Sources and updates

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