← All recalls
Medical Device

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Recall date: 2026-08-26 · Source: FDA_DEVICE
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Reason for recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Units affected
24 units
Description
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
View official recall notice →