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Syva EMIT 2000 Quinidine Assay
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MEDICAL DEVICE RECALLMODERATE

Syva EMIT 2000 Quinidine Assay

Siemens recalls Syva EMIT 2000 Quinidine Assay over precision issues that may cause elevated readings and risk of cardiac arrhythmias.

What to do

Do not use the Syva EMIT 2000 Quinidine Assay (REF 4Q019UL) from affected lots. Contact Siemens Healthcare Diagnostics for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2975-2026
Agency
FDA
Firm
Siemens Healthcare Diagnostics, Inc.
Recall ID
99446
Status
ONGOING

Why it was recalled

Siemens Healthcare Diagnostics is recalling the Syva EMIT 2000 Quinidine Assay (REF 4Q019UL) due to unacceptable precision performance in certain lots, which may lead to erroneously elevated quinidine measurements. This could result in sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL–Z-2975-202600842768001048
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL2597, 2627, 2709Z-2976-202600842768023293

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-18 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification