Stanbio recalls Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagent due to stability problems causing unreliable test results. Affected lots may produce inaccurate test outcomes.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Stanbio is recalling Cardinal Health's Beta-Hydroxybut: a blood test reagent that may give inaccurate results because it degrades over time. This could lead to incorrect medical diagnoses if used without proper quality control.
The reagent degrades over time, leading to test results that fall outside expected quality control ranges. This could cause inaccurate blood test results, potentially affecting medical decisions.
Healthcare providers using this reagent for blood tests may be affected. Patients receiving tests with this reagent could face inaccurate results, though the risk is low.
Check for the lot numbers 166355, 165053, 163944, or 162092 on the reagent packaging. The product is sold under the brand name Cardinal Health Beta-Hydroxybutyrate.
Look for lot numbers 166355, 165053, 163944, or 162092 on the reagent packaging.
The reagent degrades over time, causing test results to fall outside expected quality control ranges, which could lead to inaccurate medical diagnoses.
Check the lot number on the packaging. If it matches the affected lots listed, contact Stanbio for guidance.
No, this is a quality control issue that could lead to inaccurate test results, not a physical safety risk.
We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.
Subject: Recall Z-2202-2021 — Stanbio Stanbio Hello, I own a Stanbio that is covered by recall Z-2202-2021 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.
