Recall Z-2965-2026— Siemens Healthcare Diagnostics Products Ltd.

Name: FDA recall Z-2965-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-13

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics Products Ltd., initiated 2026-07-13. It names one FDA 510(k) clearance: K091361. Product: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly. Reason: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive..

Recalling firm: Siemens Healthcare Diagnostics Products Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-13
Firm location: Caernarfon, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K091361 — IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEMSiemens Healthcare Diagnostics·cleared 2009-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.