Siemens Healthcare recalls Syva EMIT 2000 Quinidine Assay due to potential inaccurate quinidine measurements, risking suboptimal patient treatment and life-threatening cardiac issues. Affected units include specific lot numbers.
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 therapy.
Siemens Healthcare is recalling Syva EMIT 2000 Quinidine Assay kits because certain batches may give inaccurate quinidine measurements. This could lead to improper treatment, including life-threatening heart rhythm problems or inadequate malaria therapy.
The assay may produce erroneously high quinidine readings in certain batches. This can cause under-treatment of malaria or improper heart rhythm management, potentially leading to serious health consequences.
Healthcare providers using the Syva EMIT 2000 Quinidine Assay for patient testing are most at risk, particularly those relying on the kit for critical cardiac and malaria treatment decisions.
Check for the lot number U1/UDI: 00842768001048 on the Syva EMIT 2000 Quinidine Assay kit. The product includes 1x28 mL and 1x14 mL components.
Look for the lot number U1/UDI: 00842768001048 on the Syva EMIT 2000 Quinidine Assay kit.
The affected lot number is U1/UDI: 00842768001048.
Certain batches of the Syva EMIT 2000 Quinidine Assay may give inaccurate quinidine measurements, risking suboptimal patient treatment.
Erroneously high quinidine readings could lead to inadequate malaria treatment or life-threatening cardiac arrhythmias.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2975-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2975-2026 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
