Siemens Healthcare Diagnostics Products Ltd. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnlyClass IIJul 13, 2026Syphilis Screen assay may contain a negative patient bias re	Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being repo	Class IIDevices	Jul 13, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnlyClass IIJul 13, 2026Syphilis Screen assay may contain a negative patient bias re	Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being repo	Class IIDevices	Jul 13, 2026