Norwood, MA, United States
Advanced Instruments, LLC recalls
2 recalls recorded since 2018, most recently on 11 March 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 March 2024
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1696-2024
- 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.
Terminated Class II Medical devices
- Recall started
- 7 February 2018
- Terminated
- 24 September 2019
- Reason
- RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.
- Distribution
- US Nationwide distribution in the states of IN, WA, NC, CA, GA, CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0640-2019
- GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labele
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.