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Enzyme Linked Immunoabsorption Assay, Treponema Pallidum recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2966-2026

Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085

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

Siemens Healthcare Dia…Aug 26, 2026

Class IIOngoingZ-2965-2026

Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981…

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

Siemens Healthcare Dia…Aug 26, 2026