Home › Device types › OTA
Mass Spectrometer For Clinical Multiplex Test Systems
FDA product code OTA · Class 2 · Clinical Chemistry
7
Registered devices
0
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
EXENT® Wash solution 1 — THE BINDING SITE GROUP LIMITEDEXENT® Analyser — THE BINDING SITE GROUP LIMITEDEXENT® Disposable MALDI plate pack — THE BINDING SITE GROUP LIMITEDEXENT® Mass calibration standard 1 — THE BINDING SITE GROUP LIMITEDEXENT® HCCA MALDI Matrix Pack — THE BINDING SITE GROUP LIMITEDEXENT® Elution buffer 1 — THE BINDING SITE GROUP LIMITEDEXENT® Diluent 1 — THE BINDING SITE GROUP LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-16 | The Binding Site Group, Ltd. | It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured |
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