therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of

FDA device recall Z-2665-2023 · posted 2023-09-29 · Open, Classified

Recall details

Recalling firm

Qiagen GmbH

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

Action taken

Qiagen 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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWD

Distribution

Worldwide - 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

Date initiated

2023-08-22

Date posted

2023-09-29

Location

Hilden, Germany