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U.S. Department of Health and Human Services

Class 2 Device Recall QIAGEN QIAstatDx

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  Class 2 Device Recall QIAGEN QIAstatDx see related information
Date Initiated by Firm May 09, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2215-2023
Recall Event ID 92540
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
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, Respiratory Syncytial Virus A+B, Bordetella
pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae
REF 691223
Code Information GTIN: 14053228038846 LOT Number: 175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783
Recalling Firm/
Qiagen GmbH
Qiagen Str. 1
Hilden Germany
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Mixed-up of materials/components
Action 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
Quantity in Commerce 368 kits
Distribution AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.