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