Is Siemens Healthcare Diagnostics Products Ltd. recalled?

Yes — a recall has been published. Reason: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

Check the device or its packaging for

Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807

Why: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Distributed: 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.¿¿¿¿¿
Company: Siemens Healthcare Diagnostics Products Ltd.
Announced: 26 August 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 13 July 2026

Source: FDA record Z-2966-2026 · retrieved 14 August 2026

Read the official notice

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