Health product recall

Vitros Chemistry Products Calibrator Kit 9

Last updated

Summary

Product
Vitros Chemistry Products Calibrator Kit 9
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Vitros Chemistry Products Calibrator Kit 9

27003933
27003931
27003932
25013527
27003993
27000401
27003116
25015413
25013760
27000793

856 8040

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive, Rochester, New York, United States, 14626

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72080

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