therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Summary
The FDA issued a Class II for therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 by Qiagen Sciences LLC. Reason: Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the .
Details
Source
Device Recall
External ID
Z-1651-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Lot/Code Info: Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022
Quantity Affected: 29 kits
Reason for Recall
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
Distribution
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-20
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 164 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-1651-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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