Stanbio recalls Synchron CX/DX/LX Beta-Hydroxybutyrate reagents due to stability issues causing inaccurate test results. Affected lots may produce false low readings in blood tests.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Stanbio is recalling Synchron CX/DX/LX Beta-Hydroxybutyrate reagents because they may become unstable and give false low results in blood tests. This could lead to incorrect health assessments if used without proper quality control.
The reagents can deteriorate over time, leading to lower than expected test results. This may cause false low readings in blood tests, potentially affecting health assessments if not corrected through proper quality control.
Users of blood tests for metabolic conditions who have the Synchron CX/DX/LX reagents with lot numbers 161020 are affected. Those using the reagents for routine blood testing may be at risk of inaccurate results.
Check for the Synchron CX/DX/LX Beta-Hydroxybutyrate reagent with catalog number B2440-180 and lot number 161020. The product is sold by Stanbio Laboratory, LP.
Look for the lot number 161020 on the reagent packaging to confirm if it is affected.
The reagents may deteriorate and produce lower than expected test results, potentially causing false low readings in blood tests.
The recall record does not specify a remedy, so check the lot number and contact Stanbio Laboratory, LP for further instructions.
The recall indicates potential instability, but the reagent is not unsafe if used within the expected stability period and quality control checks are performed.
We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.
Subject: Recall Z-2201-2021 — Stanbio Stanbio Hello, I own a Stanbio that is covered by recall Z-2201-2021 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.
