FDA-Device2026-08-26Class IIPROCESSING DEFECT
Siemens Immulite 2000 Syphilis Screen assay recalled for false-negative test results
What this means
Certain lots of the Siemens Immulite 2000 Syphilis Screen diagnostic assay may incorrectly report low-level positive results as negative. This means some patients with syphilis could receive a false negative result, delaying diagnosis and treatment.
- If your laboratory uses lot D387 of this assay, contact Siemens Healthineers immediately for instructions.
- Review any recent syphilis screening results from this lot for potentially affected patients.
- Retest any patients from the affected lot with an alternative validated syphilis assay.
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
24 units
Manufactured in
Glyn Rhonwy, Caernarfon, United Kingdom
Products
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2965-2026More Siemens recalls
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