Cognision recalls clinical-grade Wave Prep cups (Model 3000) due to potential Burkholderia cepacia contamination. Affected kits contain specific lot codes. No remedy provided in official notice.
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Cognision is recalling clinical-grade Wave Prep cups (Model 3000) that may contain Burkholderia cepacia bacteria. This contamination could pose health risks to users, especially those with compromised immune systems.
The product may contain Burkholderia cepacia, a bacterium that can cause serious infections in people with weakened immune systems. This contamination risk is specific to the clinical-grade Wave Prep cups used in medical settings.
Users of the Cognision Subject Kit (Clinical Grade) Model 3000 with specific lot codes are affected. Individuals with weakened immune systems may be at higher risk from potential bacterial contamination.
Check for lot codes NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, or NNX-100001561 on the packaging. The Wave Prep cups are part of the Cognision Subject Kit (Clinical Grade) Model 3000.
Look for lot codes NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, or NNX-100001561 on the packaging.
The official recall notice does not provide a remedy.
The recall notice states the product may be contaminated with Burkholderia cepacia, a bacterium that can cause serious infections in people with weakened immune systems.
Affected lot codes are NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, and NNX-100001561.
We’ve drafted a message you can send Cognision to request your refund or repair — edit it as you like.
Subject: Recall Z-0675-2020 — Cognision Cognision Hello, I own a Cognision that is covered by recall Z-0675-2020 from Cognision. 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.
