Recall Z-2215-2023 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Qiagen GmbH
QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, P
| Date | Jul 21, 2023 (initiated May 9, 2023) |
| Status | Open, Classified |
| Reason | If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported |
| Root cause | Mixed-up of materials/components |
| Action | Qiagen issued Urgent Medical Device Correction Correction letter via e-mail on 5/9/23. For bounced e-mails, alternative suitable contacts will be identified. Letter states reason for recall, health risk and action to take: Please check if you have remaining stock of LOT 175010712. Do not use the remaining stock of cartridges of LOT 175010712. Dispose of it immediately in accordance to your national and local safety and environmental regulations. Please contact QIAGEN Technical Services for a free-of-charge replacement. Review this notice with your laboratory/medical director. IMPORTANT: Fo |
| Quantity | 368 kits |
| Distribution | AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.