Class 2 Device Recall QIAstatDx Respiratory SARSCoV2 Panel

• Date Initiated by Firm: July 15, 2020
• Create Date: September 04, 2020
• Recall Status: Terminated on March 22, 2021
• Recall Number: Z-2938-2020
• Recall Event ID: 86149
• Product Classification: COVID-19 multi-analyte respiratory panel nucleic acid devices - Product Code QLT
• Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.
• Code Information: lots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508
• Recalling Firm/ Manufacturer: Qiagen Sciences LLC; 19300 Germantown Rd; Germantown MD 20874-1415
• For Additional Information Contact: QIAGEN Technical Service; 800-362-7737
• Manufacturer Reason for Recall: There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.
• FDA Determined Cause: Material/Component Contamination
• Action: On July 15, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers to inform them of the increased rate of potential false positive results for the Influenza A (no subtype) target. Customers were instructed to do the following: l -Please review and reassess all Influenza A (no subtype) positive samples tested with the affected lots. -Please note that as per Instructions for Use if only an Influenza A signal is present and no additional signal for any of the subtypes is generated, it can be due to either low concentration or, in very rare cases, a new variant or any Influenza A strain other than H1 and H3 (e.g., H5N1, which can infect humans). Such result should, therefore, be interpreted in the context of epidemiological and clinical plausibility. -If you have used the affected lot/s and you have concerns about previously generated Influenza A (no subtype) positive results on the basis of which patient treatment/management was initiated, we recommend a review of the corresponding Influenza A (no subtype) positive results. -For continued use of the affected QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 LOTs, Flu A (no subtype) positive results should be retested with an alternate method and interpreted in the context of current epidemiology and clinical presentation. -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. -Please complete Acknowledgement of Receipt attached to this letter by 29 July 2020. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
• Quantity in Commerce: 1474 kits
• Distribution: US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.