therascreen® EGFR RGQ PCR Kit 1Recalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04053228002062), received between Mar 17, 2020 and Mar 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Insufficient Device Problem Information2

Patient problems

Therapeutic Response, Decreased2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER OBTAINED A FALSE POSITIVE G719X RESULT USING THE TEST AND REPORTED IT TO THE PHYSICIAN. TREATMENT AND STATUS OF PATIENT UNKNOWN. NO INJURY REPORTED.
Patient problems: Therapeutic Response, Decreased
MAUDE report 9845345 ↗
InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER OBTAINED A FALSE POSITIVE G719X RESULT USING THE TEST AND REPORTED IT TO THE PHYSICIAN. TREATMENT AND STATUS OF PATIENT UNKNOWN.
Patient problems: Therapeutic Response, Decreased
MAUDE report 9845343 ↗

Device details

UDI-DI	`04053228002062`
Brand	therascreen® EGFR RGQ PCR Kit
Model	1
Catalog no.	870121
Company	QIAGEN GmbH
Product code	OWD · Somatic Gene Mutation Detection System
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 6, 2020

Device type (GMDN): Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the EGFR mutation status or mRNA expression of the EGFR gene, using a nucleic acid technique (NAT).

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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