Reported Aug 26, 2026 · Ongoing · Updated Sep 7, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 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 · N/A
Is this the product you have?
2 of 2 products · 3 lot codes
| Product number | Lot codes and dates |
|---|---|
L2kSY2 |
|
L2KSY6 |
|
- Lot codes and dates
- Lot Code
D387/UDI(s):L2KSY2-00630414999791L2KSY6 - 00630414999807
- Lot Code
- Amount recalled
- 478 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.
Want the full recall guide?
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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