Official recall notice
FDA DeviceClass IINotable
FDA Recall: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/1048
- Recall date
- 2026-08-26
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Product description
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Affected products
Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807