Recall Z-0545-2024
Ortho-Clinical Diagnostics, Inc. · initiated October 10, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Codes / lots: 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…
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0545-2024
- Initiated
- October 10, 2023
- Posted by FDA
- December 13, 2023
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 176 units
- Distribution
- US Nationwide. Global Distribution.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0543-2024 Class II | VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code…During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0544-2024 Class II | VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440…During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0546-2024 Class II | VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0547-2024 Class II | VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |