Home › Device types › MWA
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
FDA product code MWA · Class 2 · Microbiology
1
Registered devices
1
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-11-28 | Roche 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 |
| 2004-07-07 | Roche Molecular Systems Inc | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent durin |
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