Z-0079-2019 Class II Terminated
FDA device recall Z-0079-2019 was initiated by Ortho-Clinical Diagnostics on Aug 15, 2018 and is designated Class II. Reason for recall: Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. The recall status is terminated (terminated Jan 10, 2022). Affected quantity: U.S.= 1255 ex-U.S.= 1504.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2018
- Initiation Date
- Aug 15, 2018
- Termination Date
- Jan 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- U.S.= 1255 ex-U.S.= 1504
Product Description
VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
Reason for Recall
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Distribution Pattern
Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Code Information
Serial Numbers : J56000024 through J56003300
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0079-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026