Framingham, MA, United States
AB Sciex, LLC recalls
2 recalls recorded since 2018, most recently on 30 August 2023. 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
- 30 August 2023
- Reason
- In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0040-2024, Z-0038-2024, Z-0037-2024, Z-0039-2024
- Citrine Triple Quad Mass Spectrometer, Part Number 5063684
- 4500MD Triple Quad Mass Spectrometer, Part Number 5032522
- API3200MD Mass Spectrometer, Part Number 4466230
- Citrine QTRAP Mass Spectrometer, Part Number 5063685
Terminated Class II Medical devices
- Recall started
- 4 October 2021
- Terminated
- 23 January 2024
- Reason
- The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of District of Columbia, Florida, Illinois, Louisiana, Maryland, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Utah, Wisconsin and the countries of Austria, Finland, Germany, Hong Kong, Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0175-2022
- Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
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.