FDAFDA · Food and drugs·Recall number Z-2966-2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Published August 26, 2026 · Recall initiated: July 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Distributor
- 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.¿¿¿¿¿
- Lot
- Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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