Stanbio recalls unlabeled Beta-Hydroxybutyrate Reagent A enzyme for unstable quality control values. This in vitro diagnostic reagent may produce inaccurate test results if used improperly.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Stanbio is recalling unlabeled Beta-Hydro:hydroxybutyrate Reagent A enzyme kits because they can become unstable and produce inaccurate test results. This affects labs using the product for in vitro diagnostics.
The reagent can deteriorate over time, leading to lower quality control values that may cause inaccurate test results. This affects the reliability of diagnostic tests but does not pose a direct physical risk to users.
Labs and healthcare providers using this unlabeled enzyme reagent for in vitro diagnostic testing are affected. The risk is low as the issue relates to test accuracy rather than immediate safety hazards.
Check for the unlabeled Beta-Hydroxybutyrate Reagent A - Enzyme (product code 2441-050U) with lot number 158894. This reagent is used in in vitro diagnostic testing.
Verify if your reagent has the product code 2441-050U and lot number 158894.
The reagent can deteriorate over time, resulting in lower than expected quality control values that may affect test accuracy.
The recall record does not specify a remedy, so check with Stanbio Laboratory, LP for guidance.
No, the hazard is limited to potential inaccurate test results, not physical harm.
We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.
Subject: Recall Z-2200-2021 — Stanbio Stanbio Hello, I own a Stanbio that is covered by recall Z-2200-2021 from Stanbio. 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.
