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Recall Observatory FDA recall evidence

Device product

VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

Z-2066-2012

May 21, 2012

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 61910
Status
Terminated
Classification
Class II
Quantity
2044
Official record key
device-enforcement:Z-2066-2012

Official wording

Reason: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.

Code information: Version 2.6.1 & Below

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.