Medline recalls Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls shipped without refrigeration. Affected units may degrade test results. Contact Medline for details.
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
Medline is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls that were shipped at room temperature instead of refrigerated. This could cause inaccurate test results if used.
The product was shipped at room temperature instead of refrigerated. This could cause the test strips to degrade, leading to inaccurate blood test results. The hazard does not pose a direct physical risk to users.
Users of the Stanbio TDM controls who purchased them between 2016 and 2017 are likely affected. Those using the devices for medical testing are at higher risk of inaccurate results.
Check for model number S-O2460605 and batch numbers 161603, 165148, 156205, 158144, 169124, 171961, or 175250. The product was sold from 2016 to 2017.
Verify the model number and batch numbers listed in the recall notice.
The product was shipped at room temperature instead of refrigerated, which could cause inaccurate test results.
Check for model number S-O2460605 and batch numbers 161603, 165148, 156205, 158144, 169124, 171961, or 175250.
The recall notice does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0404-2022 — Medline Medline Hello, I own a Medline that is covered by recall Z-0404-2022 from Medline. 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.
