Class IIDeviceOngoing

Siemens Healthcare Diagnostics Products Ltd.

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

Reason for recall

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

Details

Recall number: Z-2966-2026
Event ID: 99447
Recall initiated: Jul 13, 2026
Classified: Aug 14, 2026
Reported: Aug 26, 2026
Quantity: 478 units
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.¿¿¿¿¿
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Caernarfon, United Kingdom
Lot / code info: Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807