Beckman Coulter recalls Emit 2000 Quinidine Assay kits with specific lot numbers due to potential for inaccurate quinidine measurements, risking suboptimal patient treatment and possible life-threatening cardiac issues.
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.
Beckman Coulter is recalling certain Emit 2000 Quinidine Assay kits because they may give incorrect quinidine measurements. This could lead to improper patient treatment, including risks of life-threatening heart rhythms or inadequate malaria treatment.
The assay kits may produce erroneously high quinidine measurements in certain lots. This can cause treatment to be less effective, potentially leading to life-threatening heart rhythm problems or inadequate malaria treatment.
Healthcare providers using the Emit 2000 Quinidine Assay kits with specific lot numbers are affected. Patients receiving treatment with these kits may be at risk of incorrect quinidine levels.
Check the lot numbers on the kit: 2597, 2627, or 2709. The product has a unique identifier (UDI) starting with 00842768023293. These kits were sold with specific reference numbers.
Look for lot numbers 2597, 2627, or 2709 on the kit packaging.
Lots 2597, 2627, and 2709 are affected.
Check the lot number on the kit: 2597, 2627, or 2709. The product has a unique identifier (UDI) starting with 00842768023293.
Incorrect quinidine measurements may lead to suboptimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2976-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2976-2026 from Beckman Coulter. 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.
