Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2 recall (Siemens Healthcare Diagnostics Products Ltd.)

Medical deviceClass IIOngoing

Summary: Siemens Healthcare Diagnostics Products Ltd. is recalling Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly. Reason: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

What is being recalled

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

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.¿¿¿¿¿ (states named: Florida, New Jersey, New York)

How to tell if yours is affected

Lot Code: D387/UDI: 00630414976891

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Siemens Healthcare Diagnostics Products Ltd. · all medical device recalls · recalls from July 2026

Official FDA record