therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Summary
The FDA issued a Class II for therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) by Qiagen Sciences LLC. Reason: False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for.
Details
Source
Device Recall
External ID
Z-0951-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Lot/Code Info: All lot numbers. GTIN number: 04053228002048
Quantity Affected: 435 kits
Reason for Recall
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
Distribution
AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-25
Company
Germantown, MD
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 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Qiagen Sciences LLC has 11 FDA actions in our database, including 11 recalls.
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 (Qiagen Sciences LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Qiagen Sciences LLC have FDA actions?
Qiagen Sciences LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0951-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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