OsmoPRO® MAX Automated Osmometer
Brand(s)
Last updated
Summary
Product
OsmoPRO® MAX Automated Osmometer
Issue
Medical devices - Performance issue
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 |
|---|---|---|
OsmoPRO® MAX Automated Osmometer |
All lots. |
OSMOPRO MAX |
Issue
Advanced instruments is issuing a recall for the device due to two issues:
1) system error messages that may delay the ability to test patient samples
2) the need for frequent calibration due to results outside the expected range when testing controls.
Recall start date: March 11, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Advanced Instruments, LLC
Two Technology Way, Norwood, Massachusetts, United States, 02062
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75286
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