Class II U.S. Food and Drug Administration

Siemens Healthineers Immulite 2000 Systems SYP recall: Syphilis Screen assay may contain a negative patient bias resulting in low

Recall published 2 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2965-2026
Published
August 26, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Siemens Healthcare Diagnostics Products Ltd.
Product type
Medical devices
Units affected
24 units
Distribution
Nationwide
Made in
United Kingdom
Lot / code info
Lot Code: D387/UDI: 00630414976891
UPC codes
00630414976891

Products covered by this recall

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00630414976891

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • D387
  • UDI

Model or item number

On the rating label, the box or the instruction sheet.

  • L2KSY2

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Siemens Healthcare Diagnostics Products Ltd. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Siemens Healthcare Diagnostics Products Ltd. — Glyn Rhonwy, Caernarfon

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Siemens Healthcare Diagnostics Products Ltd. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00630414976891; lot code D387, UDI; model number L2KSY2. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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