Z-1287-2019 Class II Terminated
FDA device recall Z-1287-2019 was initiated by Ortho-Clinical Diagnostics on February 20, 2019 and is designated Class II. Reason for recall: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems The recall status is terminated (terminated September 15, 2021). Affected quantity: 55 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- February 20, 2019
- Termination Date
- September 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
Product Description
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Reason for Recall
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Distribution Pattern
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.
Code Information
Serial Numbers: 56003270 & above UDI: 10758750002740