FDA recall Z-1291-2019

Ortho-Clinical Diagnostics · Class II · device

Product

VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 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

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.

Key facts

Status: Terminated
Initiation date: 2019-02-20
Report date: 2019-05-15
Termination date: 2021-09-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1291-2019