Home › Hologic, Inc. › APTIMA
APTIMA
Hologic, Inc. · Model TIGRIS,TRICH ROOMTEMP,V1,250T,READY MADE · UDI-DI 15420045514980
1
510(k) clearances
30
Adverse events
4
Recalls
14
Facilities
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.