# FDA recall Z-2665-2023

> **Qiagen GmbH** · Class II · device recall initiated 2023-08-22.

## Product

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)

## 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

## 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

## Key facts

- **Recall number:** Z-2665-2023
- **Recalling firm:** Qiagen GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-22
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hilden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2665-2023

## Citation

> AI Analytics. FDA recall Z-2665-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2665-2023. Source: US FDA. Licensed CC0.

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