Recall Z-0175-2022— AB SCIEX
Class II · Terminated
Class II FDA medical device recall by AB SCIEX, initiated 2021-10-04, terminated 2024-01-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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..
- Recalling firm
- AB SCIEX
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-04
- Terminated
- 2024-01-23
- Firm location
- Concord, N/A, Canada
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.