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Health Canada Medical devices

Vitros Chemistry Products Calibrator Kit 9

Issued October 26, 2022
Issue
Ortho determined that data release versions (DRV) 6194 through 6200 of the calibration diskette contain an erroneous value in the calibration mathematics for gen 22 of Vitros phyt slides. This erroneous value prevents Vitros 250/350 chemistry systems from completing a successful calibration on all lots of gen 22 of Vitros phyt slides. Attempting to calibrate gen 22 of Vitros phyt slides using a DRV from the range listed above will result in condition code "6md, calibration malfunction" and a failed calibration. Recall start date: October 14, 2022
Hazard description
Performance
Product
Product name
Vitros Chemistry Products Calibrator Kit 9
Reference
ID
RA-72080