Device recall

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

FDA recall source

Recall number

Z-2966-2026

Event id

99447

Status

Ongoing

FDA classification

Class II

Recalling firm

Siemens Healthcare Diagnostics Products Ltd.

Report date

Aug 26, 2026

Initiated

Jul 13, 2026

Center classification date

Aug 14, 2026

Reason

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Quantity

478 units

Code info

Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807

Distribution

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.¿¿¿¿¿

Voluntary or mandated

Voluntary: Firm initiated

Location

Caernarfon, United Kingdom