medical MODERATE Updated 2026-08-26

Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Scr

See all recalls from Siemens Healthcare Diagnostics Products Ltd. →

Recalled Product

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

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Hazard / Issue

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: D387/UDI: 00630414976891

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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