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Siemens Healthcare Diagnostics Products Recalls
2 recalls on record · August 26, 2026 to August 26, 2026 · Medical Devices
August 26, 2026Medical DevicesFDA
Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Hazard: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
August 26, 2026Medical DevicesFDA
Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Hazard: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.