fda_recall · device_recall · high
The Binding Site Group, Ltd. — Class II recall: Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number:…
- Event date
- 2026-06-17 00:00:00Z
- Observed
- 2026-07-09 22:52:12Z
- Source ID
- Z-2362-2026
- Payload hash
- 1fe8583ee967e1fcc523e45c…
Summary
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. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protei… Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.