- Recalling firm
- Milestone S.R.L.
- Reason for recall
- There is a possibility of reagent leakage from the specimen container.
- Affected products (lot / model / serial)
- UDI-DI: 08052478981055; Lot Number: 2024-09
- Units affected
- 61600 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
- Firm location
- Sorisole, Italy
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1944-2026
- Recall initiated
- March 9, 2026
- FDA classification date
- April 24, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98632
- Last updated on HTM Vibe
- July 24, 2026