FDA-Device2026-08-26Class IIPROCESSING DEFECT
Siemens Healthineers Immulite 2000 Syphilis Screen recalled for false-negative test results
What this means
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen test kits may incorrectly report positive syphilis results as negative. This could allow infected patients to go undiagnosed. The affected lot codes are L2KSY2/10489085 and L2KSY6/10488319.
- If your laboratory uses these kits, check your lot numbers against L2KSY2/10489085 and L2KSY6/10488319.
- Contact Siemens Healthineers for guidance on inventory and next steps.
- Review recent syphilis test results from affected kits with your laboratory director.
The agency's original wording
Hazard
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.¿¿¿¿¿
Affected count
478 units
Manufactured in
Glyn Rhonwy, Caernarfon, United Kingdom
Products
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2966-2026More Siemens recalls
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