United StatesSiemens Healthineers Immulite 2000 Systems SYP Syphilis Screen kits (REFs L2KSY2/D 10471981; L2kSY2/10489085; L2KSY6/10488319; Lot Code D387; UDIs 00630414976891, L2KSY2‑00630414999791, L2KSY6‑00630414999807) are affected. They were recalled because the Syphilis Screen assay may have a negative patient bias causing low reactive patient results to be reported as nonreactive.
What's being recalled
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Recalling firm: Siemens Healthcare Diagnostics Products Ltd., Caernarfon, United Kingdom.
How to identify it
Lot Code: D387/UDI: 00630414976891 Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
The hazard
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.¿¿¿¿¿
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)