Advanced Instrument OsmoPRO MAXRecalls & reported problems

Advanced Instruments, LLC · The OsmoPRO MAX provides osmolality measurement of serum, plasma, and urine, and is intended for use by trained healthcare professionals. Osmolality is a valuable clinical tool used in the diagnosis and treatment of patients. It is a quick and effective test to help evaluate the body’s water balance or its ability to produce and concentrate urine, to investigate low sodium levels (hyponatremia), to detect the presence of toxins in the body, and to monitor the osmolality of patients undergoing osmotically active drug therapies such as mannitol, which is used to treat cerebral edema. · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Mar 11, 2024Open, Classified
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
Z-1696-2024 · Root cause: Under Investigation by firm · FDA record ↗

Device details

UDI-DI	`00816068021150`
Brand	Advanced Instrument OsmoPRO MAX
Model	OsmoPRO MAX
Catalog no.	OSMOPRO MAX
Company	Advanced Instruments, LLC
Product code	JJM · Osmometer For Clinical Use
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 26, 2026

Device type (GMDN): Osmometric analyser IVD

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the osmotic concentration of a clinical specimen (e.g., urine, serum, tears, sweat) by comparing its freezing-point depression curve, or vapour-pressure depression curve, with that of a standard solution. It is often used to assess an abnormal osmolar ratio which may indicate disease [e.g., renal disease, diabetes insipidus, secretion of abnormal levels of antidiuretic hormone (ADH)].

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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