FDA Device Intelligence
Home › Hologic, Inc. › MTD

MTD

Hologic, Inc. · Model Amplified Mycobacterium Tuberculosis · UDI-DI 15420045500303

MWA Prescription
0
510(k) clearances
1
Adverse events
2
Recalls
4
Facilities

Recalls

DateFirmReason
2012-11-28Roche Molecular Systems, Inc.The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both
2004-07-07Roche Molecular Systems IncAn increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.

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 docs
Data 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.