Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chr
Summary
The FDA issued a Class II for Cliquid MD version 3.4 software used in conjunction with Analyst MD software on by AB SCIEX. 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 hidd.
Details
Source
Device Recall
External ID
Z-0175-2022
Action Date
2021-11-03
Status
Terminated
Category
device
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
Lot/Code Info: Software version 3.4
Quantity Affected: 30
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.
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, Japan, Norway, Spain, Switzerland, United Kingdom, Italy, France, and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-04
Company
Concord, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AB SCIEX) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AB SCIEX have FDA actions?
This is the only FDA action we have on record for AB SCIEX in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0175-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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