Z-0653-2019 Class II Terminated
FDA device recall Z-0653-2019 was initiated by Ortho-Clinical Diagnostics on Oct 19, 2018 and is designated Class II. Reason for recall: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. The recall status is terminated (terminated Jan 24, 2022). Affected quantity: 728.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Oct 19, 2018
- Termination Date
- Jan 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 728
Product Description
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Reason for Recall
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Distribution Pattern
US Nationwide Distribution
Code Information
Product Code: 6802445 UDI: 10758750012343 Serial Numbers: J46000108-J46001132
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0653-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026