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Health product recall

Vitros Chemistry Products Calibrator Kit 20

Last updated

Summary

Product
Vitros Chemistry Products Calibrator Kit 20
Issue
Medical devices - Performance issue
What to do

Review/post notice (forward if product is distributed), discontinue/discard inventory, return reply form. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Vitros Chemistry Products Calibrator Kit 20

2022

680 1704

Issue

The Vitros Chemistry Products Calibrator Kit 20 is used to calibrate Microtip assays C3, C4, IgM, IgA, IgG, and transferrin. Vitros Calibrator Kit 20 contains five calibrator levels. Although lot 2022 met all initial release criteria, vial to vial variability was subsequently observed during routine internal testing. This prompted an investigation that confirmed that the level 5 calibrator exhibited vial to vial variability which may cause a bias for all six affected assays, although to varying magnitudes.

Recall start date: May 9, 2023

Additional information

Details
Original published date: 2023-05-19
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-73695