Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28586 |
| Brand Name: | QIAstat-Dx Gastrointestinal Panel |
| Model: | |
| Affected: | cat. no. 691411 |
| Software version: | |
| Recalling Organisation: | Qiagen GmbH Qiagen Strasse 1 Hilden 40724 Germany |
| Contact Information: | |
| Manufacturer: | Qiagen GmbH |
| Issue: | The manufacturer has become aware that the reaction chambers contain incorrect primer–probe mixes. If an affected cartridge is used, several possibilities for false-negative, false-positive, or a combination of both false-negative and false-positive results could occur. |
| Recall action type: | Correction |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/11/2021 |
