QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Qiagen GmbH
- Reason for Recall:
- Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Product Codes/Lot Numbers:
GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2245-2023
Related Recalls
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
If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated