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Siemens Healthineers Immulite 2000 SYP Syphilis Screen
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MEDICAL DEVICE RECALLMODERATE

Siemens Healthineers Immulite 2000 SYP Syphilis Screen

Siemens Healthineers recalls Immulite 2000 SYP Syphilis Screen due to negative bias risk.

What to do

Contact Siemens Healthcare Diagnostics for instructions on returning affected assay kits and for replacement or corrective action.

Recalled
Listed
Updated
Recall No.
Z-2965-2026
Agency
FDA
Firm
Siemens Healthcare Diagnostics Products Ltd.
Recall ID
99447
Status
ONGOING

Why it was recalled

Siemens Healthineers is recalling the Immulite 2000 Systems SYP Syphilis Screen assay because the test may contain a negative patient bias, causing low reactive patient results to be reported as nonreactive. This could lead to missed syphilis diagnoses and delayed treatment.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Siemens Healthineers Immulite 2000 Systems SYP Syphilis ScreenLot code: D387

ProductRecall #UDI-DI
REF:L2KSY2(D)/10471981 IVD, RxOnlyZ-2965-202600630414976891
REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnlyZ-2966-202600630414999791, 00630414999807

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification