Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics has recalled 478 units of the Immulite 2000 Systems Syphilis Screen assay due to a negative patient bias that may cause low reactive patient results to be incorrectly reported as nonreactive. The affected units were distributed worldwide, including across Florida, New Jersey, and New York in the United States, as well as numerous countries in Europe, Asia, the Middle East, South America, and Africa. The recalled lot codes are D387 with UDI numbers L2KSY2-00630414999791 and L2KSY6-00630414999807.
The source record does not specify what affected consumers or healthcare facilities should do regarding this recall.
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: 478 units Lot/code info: Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.