Qiagen GmbH Qiagen Str. 1 Hilden Germany QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respirat Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respirat
Brand
Qiagen GmbH Qiagen Str. 1 Hilden Germany
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
GTIN: 14053228038846 LOT Number: 175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783
Qiagen GmbH Qiagen Str. 1 Hilden Germany is recalling QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucle due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Qiagen issued Urgent Medical Device Correction Correction letter via e-mail on 5/9/23. For bounced e-mails, alternative suitable contacts will be identified. Letter states reason for recall, health risk and action to take: Please check if you have remaining stock of LOT 175010712. Do not use the remaining stock of cartridges of LOT 175010712. 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. IMPORTANT: 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 19. May 2023. Actions taken by QIAGEN QIAGEN was able to identify the root cause of the issue and has implemented immediate actions to ensure that the currently produced cartridges will not cause this issue moving forward. If 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, AR, CA, FL, GA, ID, KS, KY, MD, MN, NJ, NY, PA, SC, TX, VA, DC
Page updated: Jan 10, 2026