FDA recall, , Moderate risk
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen
The Syphilis Screen assay may have a negative patient bias, causing low reactive results to be reported as nonreactive.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics Products Ltd. recalled its Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen assay because it may contain a negative patient bias, resulting in low reactive patient results being reported as nonreactive.
The recall began July 13, 2026, and was added to the FDA's Enforcement Report on August 14, 2026, with distribution in Florida, New Jersey, New York, and worldwide in countries including Austria, Brazil, France, Germany, Italy, Spain, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
- UDI-DI
- 00630414976891
- Lot code
- D387
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
- UDI-DI
- 00630414999791
- 00630414999807
- Lot code
- D387
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Florida, New Jersey, New York 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.¿¿¿¿¿
- Company
- Siemens Healthcare Diagnostics Products Ltd.Caernarfon, United Kingdom
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99447
- Recall numbers
- Z-2965-2026 to Z-2966-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
