Z-2290-2020Class II

therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

Name: Z-2290-2020 therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Creator: Qiagen Sciences LLC
Published: 2020-04-08
License: https://open.fda.gov/license/

Qiagen / initiated 2020-04-08 / Terminated

FDA source

Qiagen Sciences LLC began a recall of therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 on 2020-04-08. FDA classified it as Class II and gives the reason as "There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2290-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-08
Posted: 2020-06-05
Terminated: 2021-06-03
Recalling firm: Qiagen
Product: therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Product code: OWG
Reason for recall: There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction notification letters dated 4/8/20 were sent to customers. Actions to be taken by the customer: For continued use of the therascreen EGFR RGQ PCR Kit (24), check the delta CT values (CT) in the sample result table for automated interpretation of results. For mutation positive results with a CT below -10.00, these should be considered invalid and retested. To implement the new cutoff for the delta CT (CT), the following new instruction replaces the Table 12 (p.46) of the therascreen EGFR RGQ PCR Kit Handbook. If you have concerns about previously generated mutation positive results with the therascreen EGFR RGQ PCR Kit (24), REF. 870121, the criteria listed above can be used for review. The mixing step described in the DNA sample assessment protocol (page 25, step 8) of the therascreen EGFR RGQ PCR Handbook dated October 2019 should also be performed after step 10 on page 36 of the mutation detection protocol. To obtain a valid qPCR result for the controls and samples, strict attention must be paid to thorough reagent mixing at each mixing step during the assay setup in accordance to the instructions for use. Forward this information to all individuals and departments within your organization who are using the therascreen EGFR RGQ PCR Kit (24), REF. 870121. If you are not the end user, please forward this notice to the product end user. Review this notice with your laboratory/medical director. Complete the Acknowledgement of Receipt form attached to this letter by April 24, 2020 and email it to [email protected]. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: [email protected] Actions taken by QIAGEN QIAGEN is revising the instructions for use as described in this notice to reduce any risk resulting from fluorescence artefacts leading to invalid runs or fals
Quantity in commerce: 530 kits within expiry
Distribution: US Nationwide.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2290-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2290-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-05

Product code OWG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)