The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics Products Ltd.

2 recalls in our database name Siemens Healthcare Diagnostics Products Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2026-08-26

Of the 2 recalls from Siemens Healthcare Diagnostics Products Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2966-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recalled for Negative Bias

    Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2965-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recall for Negative Bias

    Siemens Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide