Recall Z-0455-2022 ยท QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Qiagen Sciences LLC
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
| Date | Nov 8, 2021 |
| Status | Terminated |
| Reason | The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur. |
| Root cause | Employee error |
| Action | On November 8, 2021, the firm began notifying customers. Customers received an Urgent Medical Device Correction Notice via email. Customers were instructed to do the following: - Please check the cartridge SNs received from LOT 210209 against the list of affected cartridges shown in Table 1 (page 1). If you have received one of the affected cartridges, please contact QIAGEN Technical Service for a free-of-charge replacement. - If you have received one of the 16 affected cartridges and have not used it, please dispose of it immediately in accordance with your national and local safety and e |
| Quantity | 376 kits |
| Distribution | Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.