Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics has recalled 24 units of its Immulite 2000 Systems SYP Syphilis Screen assay (Lot Code D387) distributed in Florida, New Jersey, New York, and multiple countries worldwide. The syphilis screening test may contain a negative patient bias that could cause low reactive patient results to be incorrectly reported as nonreactive, potentially missing cases of syphilis infection.
The recall affects medical facilities that received this specific lot of the diagnostic assay. The source document does not specify a remedy or corrective action for affected consumers or healthcare providers.
Written by software from the official notice below. Not reviewed by a lawyer.
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Reason for recall: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. 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.¿¿¿¿¿ Quantity: 24 units Lot/code info: Lot Code: D387/UDI: 00630414976891
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.