Recall Z-1978-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
NeuMoDx Molecular Inc
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
| Date | May 4, 2021 |
| Status | Terminated |
| Reason | There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays. |
| Root cause | Material/Component Contamination |
| Action | URGENT MEDICAL DEVICE CORRECTION notification letters dated 5/4/21 were sent to customers. Actions Required by Customers 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 Medical Device Correction Notice with all users of the NeuMoDxTM Cartridges in your facility to ensure they are aware of this notice. 3. If you have already used NeuMoDxTM Cartridges from any of these lots in |
| Quantity | 620 cases (29,760 cartridges total) |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.