Qiagen GmbH: Medical Device Recall in 2023 - (Recall #: Z-2665-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

therascreen ¿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)

Product Classification:

Class II

Date Initiated: August 22, 2023

Date Posted: October 11, 2023

Recall Number: Z-2665-2023

Event ID: 92991

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

Status: Ongoing

Product Quantity: N/A

Code Information:

GTIN number: 04053228002048 All lots that have an expiry date of March 2023 or later

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated