Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NeuMoDx Flu AB/RSV/SARSCoV2 Vantage Test Strip

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall NeuMoDx Flu AB/RSV/SARSCoV2 Vantage Test Strip see related information
Date Initiated by Firm May 13, 2022
Create Date June 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-1251-2022
Recall Event ID 90275
Product Classification COVID-19 multi-analyte respiratory panel nucleic acid devices - Product Code QLT
Product NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Code Information UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
Recalling Firm/
Manufacturer		 NeuMoDx Molecular Inc
1250 Eisenhower Pl
Ann Arbor MI 48108-3281
For Additional Information Contact QIAGEN Technical Services
800-362-7737
Manufacturer Reason
for Recall		 There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
FDA Determined
Cause 2		 Process control
Action On May 13, 2022, the firm distributed Urgent Medical Device Correction letters to impacted customers. The letter informed customers of the reduced analytical sensitivity for Flu A, SARS-CoV-2, and RSV. The firm also specified that only the RSV target showed a similar reduction in clinical sensitivity; Influenza A and SARS-CoV-2 did not show a reduction in clinical sensitivity. Influenza B is not affected by this issue. The letter reminded users that negative results do not preclude infection with Influenza virus, RSV, and/or SARS-CoV-2, and the device should not be used as the sole basis for patient management and treatment decisions. Customers should share the notice with all affected users. If you have any questions regarding this recall, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com.
Quantity in Commerce 459 kits US; 1626 kits OUS
Distribution Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
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.
-
-