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fda_recall · device_recall · high

Siemens Healthcare Diagnostics, Inc. — Class II recall: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Event date
2026-08-26 00:00:00Z
Observed
2026-09-08 04:20:30Z
Source ID
Z-2975-2026
Payload hash
1058441e7106c12ff6e02088…

Summary

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial the… Status: Ongoing.

Entities

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Frequently asked questions

Has Siemens Healthcare Diagnostics, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 9 total FDA actions tied to Siemens Healthcare Diagnostics, Inc.: 0 warning letters, 9 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-26; Argus observed and indexed it on 2026-09-08.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Siemens Healthcare Diagnostics, Inc. — Class II recall: Syva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2975-2026
MLA
"Siemens Healthcare Diagnostics, Inc. — Class II recall: Syva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2975-2026.
Chicago
Argus HQ Research. "Siemens Healthcare Diagnostics, Inc. — Class II recall: Syva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2975-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_siemens_healthcare_diagnostics_inc_z_2975_2026_2026,
  title = {Siemens Healthcare Diagnostics, Inc. — Class II recall: Syva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2975-2026},
  note = {Accessed: September 8, 2026}
}

Informational only. Not legal, financial, or medical advice.

Siemens Healthcare Diagnostics, Inc. — Class II recall: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL · Argus HQ