- Recalling firm
- Siemens Healthcare Diagnostics Products Ltd.
- Reason for recall
- Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
- Affected products (lot / model / serial)
- Lot Code: D387/UDI: 00630414976891
- Units affected
- 24 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿
- Firm location
- Caernarfon, United Kingdom
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2965-2026
- Recall initiated
- July 13, 2026
- FDA classification date
- August 14, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99447
- Last updated on HTM Vibe
- September 8, 2026