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Vitros chemistry products calibrator kit 9
Official notice
26 Oct 2022
Last checked
26 Oct 2022
An official Health Canada notice concerns Vitros chemistry products calibrator kit 9. 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 Published 2022-10-26.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72080
Official notice
2022-10-26
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Ortho-clinical Diagnostics, Vitros Chemistry Calibrator Kit 9.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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