OsmoPRO MAX Clinical Osmometer Recall for Software Errors and Result Inaccuracy
Advanced Instruments is recalling OsmoPRO MAX Osmometers because system errors may delay testing and produce inaccurate results in clinical laboratories.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a clinical diagnostic device with system errors that may delay testing and produce inaccurate results. While no illnesses or injuries have been reported, the potential for diagnostic inaccuracy in a clinical setting represents a meaningful risk of harm to patient care.
Plain-English summary
Advanced Instruments, LLC has recalled the OsmoPRO MAX Automated Osmometer, a medical device used in clinical laboratories to measure osmolality of serum, plasma, and urine samples. The recall affects 58 units worldwide, including devices distributed across the United States, Canada, and multiple European and Asian countries.
The device may encounter system error messages that delay the ability to test patient samples. Additionally, the device may require frequent recalibration when test results fall outside the expected range. These issues may impact the timeliness and accuracy of osmolality measurements in clinical settings.
Clinical laboratories currently using affected devices should contact Advanced Instruments directly for instructions. The U.S. Food and Drug Administration classified this as a Class II recall. A complete list of affected serial numbers is available in the FDA recall notice (Z-1696-2024).
The recalled product
- Product
- OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0
- Manufacturer
- Advanced Instruments, LLC
- Affected units
- 58
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00816068021150
- Serial Numbers: 23030208A
- 23050414A
- 23050417A
- 23010059A
- 23040283A
- 23010014A
- 23020166A
- 23040284A
- 23020159A
- 23050410A
- 23030236A
- 23020165A
- 23020156A
- 23020161A
- 23030239A
- 23030210A
- 23030233A
- 23030232A
- 23020158A
Distribution
Distributed nationwide across the United States.
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