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Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Recalled August 26, 2026 · FDA recall Z-2966-2026 · Siemens Healthcare Diagnostics Products
Hazard
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. · FDA Class II
Units
478 units
Sold at
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.¿¿¿¿¿
Description
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Manufacturer(s)
Siemens Healthcare Diagnostics Products Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →