Xpert TV
CEPHEID · Model GXTV-10 · UDI-DI 07332940001001
OUY
Prescription
2
510(k) clearances
30
Adverse events
4
Recalls
14
Facilities
Description
Xpert TV kit; 10 test kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.