Recall Z-0543-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
| Date | Dec 13, 2023 (initiated Oct 10, 2023) |
| Status | Open, Classified |
| Reason | 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 rele |
| Root cause | 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 d |
| Quantity | 63 units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM Ortho-Clinical Diagnostics, Dec 22, 2008 |