Class 2 Device Recall NeuMoDx

• Date Initiated by Firm: February 18, 2022
• Create Date: April 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1000-2022
• Recall Event ID: 89846
• Product Classification: Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
• Product: NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100
• Code Information: Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431. GTIN: 10814278020274
• Recalling Firm/ Manufacturer: NeuMoDx Molecular Inc; 1250 Eisenhower Pl; Ann Arbor MI 48108-3281
• For Additional Information Contact: SAME; 734-477-0111
• Manufacturer Reason for Recall: Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
• FDA Determined Cause: Material/Component Contamination
• Action: QIAGEN issued customer Urgent Medical Device Correction notification via email firstly by English (then in local language if required)on 2/18/22. Letter states reason for recall, health risk and action to take: 1. IMMEDIATELY discontinue use of the product and discard remaining inventory in accordance with your national and local safety and environmental regulations. Please contact QIAGEN Technical Service for a free-of-charge replacement of scrapped inventory. 2. Share this Field Safety Corrective Action with all users of the NeuMoDx Cartridges in your facility to ensure they are aware of this notice. 3. If you have already used NeuMoDx Cartridges from any of these lots in combination with the NeuMoDx SARS-CoV-2 Assay, the NeuMoDx Flu-A-B/RSV/SARS-CoV-2 Assay and NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection please review all SARS-CoV-2 positive results to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. Note: results for targets other than SARS-CoV-2 are not impacted by this Urgent Field Safety Corrective Action. 4. Complete the attached response form and return to Quality.Communications@qiagen.com to confirm receipt of this notification. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com
• Quantity in Commerce: 773 (72 US and 701 ROW) cases (48 cartridges/case)
• Distribution: Worldwide distribution - US Nationwide distribution in the states of OH, MO, VA, MI, MI, FL, MD, IA, NY, MO and the countries of Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong, France, Denmark, Slovenia.
• 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.