Official recall notice

FDA DeviceClass IINotable

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

Recall date
2026-08-26
FDA class
Class II

Why it was recalled

Hazard

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

Product description

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

Affected products

Lot Code: D387/UDI: 00630414976891

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