Siemens Healthcare Diagnostics Products Ltd. Recalls
2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (2)
- Class II
July 13, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
- Class II
July 13, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
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