Siemens Healthineers Immulite 2000 Syphilis Screen Recall: False Negative Risk
Siemens Healthineers recalls Immulite 2000 Syphilis Screen systems that may report false negatives for syphilis tests, risking undetected infections. Affected units include specific lot codes and reference numbers.
Lower-risk recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
What happened, in plain English
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen systems that might incorrectly show nonreactive results for syphilis tests, potentially missing infections. This could lead to undiagnosed syphilis cases if the test fails to detect the disease properly. Read more at govinfonow.com/recall/697890-siemens-healthineers-immulite-2000-syphilis-screen-recall-false-negative-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/697890-siemens-healthineers-immulite-2000-syphilis-screen-recall-false-negative-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2966-2026
Cite this page
“Siemens Healthineers Immulite 2000 Syphilis Screen Recall: False Negative Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697890-siemens-healthineers-immulite-2000-syphilis-screen-recall-false-negative-risk. Based on FDA recall #Z-2966-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2966-2026%22&limit=1).
Why it’s dangerous
The syphilis screen assay may incorrectly report a nonreactive result when the patient actually has syphilis. This false negative could lead to undiagnosed syphilis infections, which can cause serious health complications if untreated.
Who’s affected
Healthcare facilities using the Immulite 2000 Syphilis Screen systems with the specified lot codes and reference numbers are affected. Patients undergoing syphilis testing with these systems may be at risk of undetected infections.
How to tell if you have this one
Check for lot codes D387 and reference numbers L2kSY2/10489085 or L2KSY6/10488319 on the system. The product is sold as an IVD (in vitro diagnostic) device for syphilis testing.
- Brand
Siemens Healthineers- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2965-2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly; Lot Code: D387/UDI: 00630414976891 | 24 units |
| Z-2966-2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly; Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807 | 478 units |
What to do — step by step
Check Product Details
Verify the lot code and reference numbers on your Immulite 2000 Syphilis Screen system to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, New Jersey, New York.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this product?
The recall indicates a potential for undiagnosed syphilis infections, but the hazard does not involve physical injury or death in normal use. This is a low-risk issue.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2966-2026 (July 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2966-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.