VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
FDA device recall Z-0546-2024 · posted 2023-12-13 · Open, Classified
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JJE
- Quantity affected
- 51 units
- Distribution
- US Nationwide. Global Distribution.
- Date initiated
- 2023-10-10
- Date posted
- 2023-12-13
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (K182063) | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |