Official recall record
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic muta
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-08-22
- Country of alert
- Germany
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04053228002048
- Brand on record
- Qiagen GmbH
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2022-02-25 · US FDA — Medical Devices
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
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