OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use — Class II medical device recall Z-1696-2024
Ongoing recall by Advanced Instruments, LLC, reported 2024-05-08, distributed nationwide. System error messages may delay the ability to test patient samples and the need for frequent calibration due
| Recall number | Z-1696-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Instruments, LLC, Norwood, MA, United States |
| Recall initiated | 2024-03-11 |
| Classified | 2024-04-29 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CZ, DE, ES, FR, IS, KR, NL, TW |
| Quantity | 58 units |
| UPC / GTIN / UDI-DI | 00816068021150 |
| Serial numbers | 22111350A, 22111354A, 22111355A, 22111358A, 22111359A, 22111360A, 22111362A, 22111363A, 22111365A, 22111367A, 22111368A, 23010011A22111364A, 23010014A, 23010015A, 23010052A, 23010053A, 23010055A, 23010059A, 23010060A, 23010061A, 23010062A, 23020155A, 23020156A, 23020157A, 23020158A and 32 more |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1696-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.