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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