Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s): recall status ⚠ Recalls found. Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s) is named in 2 official recalls in our current data:
FDA Class II recall Z-2965-2026 — Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.FDA Class II recall Z-2966-2026 — Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. Source checks: October 22, 2026 at 6:00 PM UTC (oldest successful check).
Sources, dates and coverage limits We collect recent notices on a six-hour schedule using a rolling 90-day source request. Older retained records may also appear. This is a recall index, not a catalogue of all products or a complete recall history.
CPSC: stored recall dates April 30, 2026 to October 22, 2026. NHTSA: stored recall dates April 24, 2026 to October 19, 2026. FDA: stored recall dates April 29, 2026 to October 14, 2026. USDA FSIS is not aggregated here. Check USDA meat, poultry and processed egg notices . EPA and U.S. Coast Guard are not aggregated. Source delays and missing identifiers can prevent a match.
Brand Siemens Healthcare Diagnostics Products Also listed as Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF Recalls naming this model FDA Class II · Medical device · August 26, 2026
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Company / brand: Siemens Healthcare Diagnostics Products recalls
Affected product: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF recall status
Official ID Z-2965-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Company / brand: Siemens Healthcare Diagnostics Products recalls
Affected product: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s) recall status
Official ID Z-2966-2026 ·
Official record ↗
See all Siemens Healthcare Diagnostics Products recalls →
Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.