Stanbio recalls Cardinal Health Beta-Hydroxybutyrate Liqui: reagents may produce inaccurate test results due to stability issues. Affected units include specific lot numbers and device models.
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 Beta-Hydroxybutyrate LiquiColor reagents for Synchron CX/LX/DX devices because they may produce inaccurate test results. This affects labs using these reagents for in vitro diagnostics.
The reagents may deteriorate over time, leading to lower than expected or out of range Quality Control values. This can cause inaccurate test results, potentially affecting diagnostic accuracy.
Laboratories using the Cardinal Health Beta-Hydroxybutyrate LiquiColor reagents for Synchron CX/LX/DX devices are most at risk. This recall impacts users who rely on these specific reagents for diagnostic testing.
Check for the product name 'Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX' and lot number 164986. The reagent is used in in vitro diagnostic testing with specific device models.
Identify the product name and lot number to confirm if it is affected.
The reagents may deteriorate over time, leading to lower than expected or out of range Quality Control values, which can cause inaccurate test results.
The recall does not specify a remedy, so check with your lab supplier for guidance on next steps.
Lot number 164986 is affected.
We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.
Subject: Recall Z-2203-2021 — Stanbio Stanbio Hello, I own a Stanbio that is covered by recall Z-2203-2021 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.
