Z-1676-2022 Class II Ongoing
FDA device recall Z-1676-2022 was initiated by Ortho-Clinical Diagnostics, Inc. on Jul 19, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 1148 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2022
- Initiation Date
- Jul 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1148 units
Product Description
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Reason for Recall
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.
Distribution Pattern
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.
Code Information
UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1676-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026