Official recall record
MassCheck® and 3PLUS1® Antimycotic Drugs/Extended Plasma Controls
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-02-20
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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