- Recalling firm
- The Binding Site Group, Ltd.
- Reason for recall
- 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-protein concentration.
- Affected products (lot / model / serial)
- Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
- Units affected
- 1
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Birmingham, N/A, United Kingdom
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2362-2026
- Recall initiated
- April 16, 2026
- FDA classification date
- June 9, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98830
- Last updated on HTM Vibe
- July 23, 2026