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U.S. Department of Health and Human Services

Class 2 Device Recall Qiagen Therascreen FGFR RGQ RTPCR Kit

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 Class 2 Device Recall Qiagen Therascreen FGFR RGQ RTPCR Kitsee related information
Date Initiated by FirmJuly 20, 2022
Create DateAugust 29, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1651-2022
Recall Event ID 90691
PMA NumberP180043 
Product Classification Somatic gene mutation detection system - Product Code OWD
Producttherascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Code Information Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022
Recalling Firm/
Manufacturer
Qiagen Sciences LLC
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information ContactSAME
240-686-7500
Manufacturer 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
FDA Determined
Cause 2
Under Investigation by firm
ActionQiagen issued July 20,2022 letter ( REF 874721) via email (A) US customers: notify customers by Urgent Medical Device Correction Letter; (B) CE customers: notify customers by Urgent Field Safety Notice (C) RUO (not IVD) customers: notify customers by Important Notice. Letter states reason for recall, health risk and action to take: For the continued use of REF 874721 therascreen FGFR RGQ RT-PCR Kit LOT 172017274 , please note the following criteria: Samples with the Overall sample result No Alteration Detected should be regarded as correct and no further actions are needed. Samples with the FGFR Alteration Detected results with Individual target result S249C Mutation Detected can be regarded as correct. This also includes samples with additional alterations detected. All other FGFR Alteration Detected results aside from S249C Mutation Detected should be disregarded and a retest for confirmatory positive result should be performed using the extracted RNA if available, or re-extracted if it is not. The following results should be assigned to the affected samples after the retest: l Retest result is positive for the same target(s)/ alteration(s): regard the result for the corresponding sample as positive. l Retest result is positive for different target(s)/ alteration(s) in the retest compared to the initial result: regard the result as indeterminate. l Retest is negative: the result for the corresponding sample should be regarded as negative l Retested sample is within an invalid run: repeat the run. l Result for individual sample is invalid in the retest: regard the result as indeterminate Forward this information to all individuals and departments within your organization who are using REF 874721 therascreen FGFR RGQ RT-PCR Kit. l If you are not the end user, please forward this notice to the product end user. l Review this notice with your laboratory/medical director. l Complete the Acknowledgement of Receipt Form attached to this letter by 28 July
Quantity in Commerce29 kits
DistributionIN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OWD
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