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U.S. Department of Health and Human Services

Class 2 Device Recall therascreen KRAS RGQ PCR Kit (24)

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 Class 2 Device Recall therascreen KRAS RGQ PCR Kit (24)see related information
Date Initiated by FirmAugust 22, 2023
Date PostedSeptember 29, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2665-2023
Recall Event ID 92991
PMA NumberP110027S012 
Product Classification Somatic gene mutation detection system - Product Code OWD
Producttherascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
Code Information GTIN number: 04053228002048 All lots that have an expiry date of March 2023 or later
Recalling Firm/
Manufacturer		 Qiagen GmbH
Qiagen Str. 1
Hilden Germany
Manufacturer Reason
for Recall		Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid
FDA Determined
Cause 2		Under Investigation by firm
ActionQiagen US issued Urgent Medical Device Correction Letter to US consignees -therascreen KRAS RGQ PCR Kit (24), REF 870021 on 8/22/23 via email. Letter states reason for recall, health risk and action to take: This notice only applies to you if you downloaded and used the current version (Revision 13, January 2023) of the Instructions for Use. If you downloaded and used the current version (Revision 13, January 2023) of the Instructions for Use as mentioned above, follow these actions: o The dilution step of CRC tissue sample is incorrectly indicated and should not be followed. Follow the correct Action as described in this notice. o For NSCLC tissue sample follow the corrected Action as described in this notice. " Forward this information to all individuals and departments within your organization who are using the therascreen KRAS RGQ PCR Kit (24), REF. 870021. " 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 September 01, 2023, and email it to quality.communications@qiagen.com. Actions taken by QIAGEN QIAGEN is working on updating the therascreen KRAS RGQ PCR Kit Instructions for Use . If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: TechService-NA@qiagen.com
DistributionWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, KS, MA, NC,NY,OR, PA, TN, TX and the countries of KR, CN
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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