Recall Z-0738-2022 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
NeuMoDx Molecular Inc
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
| Date | Jan 21, 2022 |
| Status | Open, Classified |
| Reason | A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product. |
| Root cause | Under Investigation by firm |
| Action | Customers were contacted by phone 21 Jan 2022 and sent a follow up email with instructions to stop using Lot 116305 S/L02, discard remaining inventory, and review all SARS-CoV-2 positive results previously obtained using the affected product lot to exclude erroneous diagnosis and treatment. Customers are to forward this information to all individuals and departments within their organization using the affected product. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com. |
| Quantity | 102 boxes |
| Distribution | US Nationwide distribution in the states of FL, MD, MI, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.