Siemens Healthcare Diagnostics, Inc.'s Complete FDA Record

FDA action counts

Enforcement history

On 2026-05-06, Argus HQ recorded a FDA recall for Siemens Healthcare Diagnostics, Inc., rated "high" severity in Argus HQ's classification: Siemens Healthcare Diagnostics, Inc. — Class II recall: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Siemens Healthcare Diagnostics, Inc., rated "high" severity in Argus HQ's classification: Siemens Healthcare Diagnostics Inc — Class II recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for Siemens Healthcare Diagnostics, Inc., rated "high" severity in Argus HQ's classification: Siemens Healthcare Diagnostics, Inc. — Class II recall: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Siemens Healthcare Diagnostics, Inc. has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Siemens Healthcare Diagnostics, Inc. has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

How many FDA actions does Argus HQ track for Siemens Healthcare Diagnostics, Inc.?

7 total: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Siemens Healthcare Diagnostics, Inc.?

August 12, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Siemens Healthcare Diagnostics, Inc. had product recalls?

Yes, 7 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Siemens Healthcare Diagnostics, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

Related enforcement actions

• Siemens Healthcare Diagnostics, Inc. — Class III recall: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catal… →
• Siemens Healthcare Diagnostics, Inc. — Class III recall: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390… →
• Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic →
• Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. →
• Siemens Healthcare Diagnostics, Inc. — Class II recall: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007… →
• Siemens Healthcare Diagnostics Inc — Class II recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma… →
• Siemens Healthcare Diagnostics, Inc. — Class II recall: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. →

Compare with

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• Siemens Healthcare Diagnostics, Inc. vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.