Ortho-Clinical Diagnostics, Inc. Recall 90681
Description: VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Ortho-Clinical Diagnostics, Inc. Recall 90681 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1676-2022 |
| Event ID | 90681 |
| Event Description | VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom. |
| Quantity | 1148 units |
| Recall Reason | Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System. |
| Device Classification | 20220914 |
| Device Code Info | UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer |
| Center Classification Date | 20220902 |
| Recall Initiation Date | 20220719 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Letter |
| Similar To |