OVERLOOKED

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Class IIOngoing

Siemens Healthcare Diagnostics Products Ltd. recalls 2 products

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Siemens Healthcare Diagnostics Products Ltd.
Reason
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.¿¿¿¿¿
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99447…

Products (2)

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

    Codes/lots: Lot Code: D387/UDI: 00630414976891Quantity: 24 unitsRecall no. Z-2965-2026Class II

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

    Codes/lots: Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807Quantity: 478 unitsRecall no. Z-2966-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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