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Recall Observatory FDA recall evidence

Device product

Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

Z-0844-2019

November 29, 2018

Class II

Product summary

Firm
Ortho Clinical Diagnostics Inc
Event
Event 81767
Status
Terminated
Classification
Class II
Quantity
4030
Official record key
device-enforcement:Z-0844-2019

Official wording

Reason: A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

Code information: Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)

Distribution pattern: Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.