Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Siemens Healthcare Diagnostics Products Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Products Ltd. · Glyn Rhonwy · Caernarfon
Is this the product you have?
- Siemens Healthineers Immulite 2000
- Systems SYP Syphilis Screen REFL2KSY2(D)/10471981 IVD, RxOnly
- Lot codes and dates
- Lot CodeD387/UDI: 00630414976891
- Amount recalled
- 24 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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