Siemens Healthcare Diagnostics, Inc.

How does FDA spell Siemens Healthcare Diagnostics, Inc.?

FDA publishes this company under 18 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Showing 8 of 18.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Siemens Healthcare Diagnostics, Inc. file in?

96 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 96.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Siemens Healthcare Diagnostics, Inc. had a recall?

openFDA lists 765 recall records naming this company across its whole history, of which 14 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

• Z-2890-2026Open, ClassifiedJIR6 July 2026

  processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

• Z-2880-2026Open, ClassifiedKLR26 June 2026

  Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

• Z-2881-2026Open, ClassifiedLFG26 June 2026

  out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

• Z-2703-2026Class IIOpen, ClassifiedPDJ8 June 2026

  The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

• Z-2398-2026Class IIOpen, ClassifiedMLM7 May 2026

  A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

Showing the 5 most recently initiated of 765.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Siemens Healthcare Diagnostics, Inc. cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Where is Siemens Healthcare Diagnostics, Inc. registered?

FDA lists 5 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.