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Siemens Healthcare Diagnostics Products Ltd. Recall

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

Updated July 13, 2026

Siemens Healthcare Diagnostics Products Ltd. is recalling Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly. Hazard: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Is the Siemens Healthcare Diagnostics Products Ltd. recalled? Yes. This product was recalled by FDA on July 13, 2026. Details below.

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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

Brands affected

Siemens Healthcare Diagnostics Products Ltd.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2966-2026
Classification
Class II
Recalled
July 13, 2026
Read the official notice

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