Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 11, 2023
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)
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. T…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Qiagen GmbH recalled therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx… - a moderate-severity action.
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx… was recalled by Qiagen GmbH in October 11, 2023. Reason: Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAI…. Check the official notice for the remedy. Verify recall #Z-2665-2023 with the FDA Devices before acting.
The recall
Qiagen GmbH issued this moderate-severity FDA Devices recall-Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAI….
- Moderate
- severity level
- Class II
- classification
- October 11, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2665-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2665-2023) was formally reported on October 11, 2023, with the manufacturer initiating the action on August 22, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Qiagen GmbH is listed as the recalling firm, operating out of Hilden, N/A. Federal records list the affected scope as N/A.
The documented reason for this recall is: 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 b… Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
N/A
Related Recalls
6
3 from same agency
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)
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2665-2023 |
| Date reported | October 11, 2023 |
| Date initiated | August 22, 2023 |
| Recalling firm | Qiagen GmbH |
| Firm location | Hilden, N/A |
| Affected scope | N/A |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2665-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Qiagen GmbH. Units affected: N/A.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2665-2023.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2665-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 11, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.