Qiagen GmbH Qiagen Str. 1 Hilden Germany 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Qiagen GmbH Qiagen Str. 1 Hilden Germany
Lot Codes / Batch Numbers
GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17
Products Sold
GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17
Qiagen GmbH Qiagen Str. 1 Hilden Germany is recalling QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharynge due to Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Recommended Action
Per FDA guidance
Qiagen issued a customer letter (Urgent Medical Device Correction (REF 691223) or Urgent Field Safety notice (REF 691214) via e-mail on 5/19/23. Letter states reason for recall, health risk and action to take: Do not use the remaining stock of cartridges of LOTs 175010704 and 175011354. Dispose of it immediately in accordance to your national and local safety and environmental regulations. " Please contact QIAGEN Technical Services for a free-of-charge replacement. " Review this notice with your laboratory/medical director. " Forward this information to all individuals and departments within your organization using the above listed kits. If you are not the end user, please forward this notice to the product end user. " Complete the Acknowledgement of Receipt Form attached to this letter by 02 June 2023. you have any questions or concerns, please contact your local QIAGEN Technical Services Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, DE, FL, GA, ID, IN, ME, NY, NC, OR, TN, TX, DC
Page updated: Jan 10, 2026