Public recall detail

OsmoPRO® MAX Automated Osmometer

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Recall Safety notice
Quick summary

Quick summary: OsmoPRO® MAX Automated Osmometer.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: OsmoPRO® MAX Automated Osmometer.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAdvanced Instruments, LLC
ProductOsmoPRO® MAX Automated Osmometer
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75286

Affected products

ProductOsmoPRO® MAX Automated Osmometer
LotAll lots.
ModelOSMOPRO MAX
Serial numberAll lots.
DescriptionOsmoPRO® MAX Automated Osmometer

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesAdvanced Instruments, LLC Two Technology Way, Norwood, Massachusetts, United States, 02062
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75286
Background{}
CompaniesAdvanced Instruments, LLC Two Technology Way, Norwood, Massachusetts, United States, 02062
AudiencesHealthcare
Source updated2024-03-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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