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Masscheck® and 3plus1® antimycotic drugs extended plasma controls

Official notice

20 Feb 2025

Last checked

20 Feb 2025

Medium riskHealth Canada

An official Health Canada notice concerns Masscheck® and 3plus1® antimycotic drugs extended plasma controls. 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 Published 2025-02-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76984

Official notice

2025-02-20

The hazard

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

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.

Recall Numbers

76984

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Affected products

Product 1

Affected products - MassCheck® Antimycotic Drugs/Extended Plasma Control Level I, Lot or serial number - 4922 1624, Model or catalog number - 0253/XT

Product 2

Affected products - 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Antimycotic Drugs/Extended, Lot or serial number - 4922 1624, Model or catalog number - 92051/XT

Product 3

Affected products - MassCheck® Antimycotic Drugs/Extended Plasma Control Level II, Lot or serial number - 4922 1624, Model or catalog number - 0254/XT

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Chromsystems Instruments Chemicals, Masscheck® And 3plus1® Antimycotic Drugs Extended Plasma Controls.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76984

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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