Recall Z-0196-2022 ยท QKP Coronavirus Antigen Detection Test System.
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
| Date | Sep 22, 2021 |
| Status | Terminated |
| Reason | Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. |
| Root cause | Device Design |
| Action | On 9/22/2021, Siemens Healthineers issued Urgent Medical Device Correction notices to all US affected customers by FedEx beginning. The customer distribution included all US customers that have received the Atellica IM and ADVIA Centaur CoV2Ag assays. Actions to be Taken by the Customer - Discontinue use of and discard the kit lots listed in the notice. - Please discuss this letter with your Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. - To receive credit for discarded product, please complete and return the f |
| Quantity | 261 kits |
| Distribution | US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.