Recall Z-2290-2020 ยท OWG
Qiagen Sciences LLC
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
| Date | Apr 8, 2020 |
| Status | Terminated |
| Reason | There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction notification letters dated 4/8/20 were sent to customers. Actions to be taken by the customer: For continued use of the therascreen EGFR RGQ PCR Kit (24), check the delta CT values (CT) in the sample result table for automated interpretation of results. For mutation positive results with a CT below -10.00, these should be considered invalid and retested. To implement the new cutoff for the delta CT (CT), the following new instruction replaces the Table 12 (p.46) of the therascreen EGFR RGQ PCR Kit Handbook. If you have concerns about previously generated |
| Quantity | 530 kits within expiry |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.