Recall Z-1696-2024 ยท JJM Osmometer For Clinical Use
Advanced Instruments, LLC
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
| Date | Apr 29, 2024 (initiated Mar 11, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Advanced Instruments issued Urgent Medical Device Recall Letter on 3/11/24 via email. Letter states reason for recall, health risk and action to take: 1. Discontinue use of your device. 2. Advanced Instruments will contact you regarding the return and exchange of your Device. Several solutions are available as needed to ensure continuity of testing. 3. For those users whose lab protocol requires the review of previous data, Advanced Instruments is available to review the data. 4. Complete and return the attached acknowledgement form. Advanced Instruments is implementing permanent corrective ac |
| Quantity | 58 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.