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Recall Observatory FDA recall evidence

Device product

VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 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

Z-1293-2019

February 20, 2019

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 82311
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-1293-2019

Official wording

Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

Code information: Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems