Health product recall

MassCheck® and 3PLUS1® Antimycotic Drugs/Extended Plasma Controls

Last updated

Summary

Product
MassCheck® and 3PLUS1® Antimycotic Drugs/Extended Plasma Controls
Issue
Medical devices - Performance
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

MassCheck® Antimycotic Drugs/Extended Plasma Control Level I

4922
1624

0253/XT

3PLUS1® Multilevel Plasma Calibrator Set MassTox® Antimycotic Drugs/Extended

4922
1624

92051/XT

MassCheck® Antimycotic Drugs/Extended Plasma Control Level II

4922
1624

0254/XT

Issue

New data from stability tests can not confirm Chromsystems instruments & Chemicals GmbH previous information regarding the storage life of calibrator 92051/XT and controls 0253/XT, 0254/XT after reconstitution at storage temperatures of +20 to +25 °c and +2 to +8 °c provided in the instructions for use and on the package inserts. In addition, adsorption effects may occur if the reconstituted products are stored in glass containers.

Recall start date: February 5, 2025

Additional information

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

Chromsystems Instruments & Chemicals GmbH

Am Haag 12, Grafelfing, Germany, 82166

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76984

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