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Class 2 Device Recall Qiagen Therascreen FGFR RGQ RTPCR Kit |
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Date Initiated by Firm |
July 20, 2022 |
Create Date |
August 29, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1651-2022 |
Recall Event ID |
90691 |
PMA Number |
P180043 |
Product Classification |
Somatic gene mutation detection system - Product Code OWD
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Product |
therascreen 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
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For Additional Information Contact |
SAME 240-686-7500
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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
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Qiagen 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 Commerce |
29 kits |
Distribution |
IN, NC, MN, TX
Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = OWD and Original Applicant = QIAGEN GmbH
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