Cardinal Health recalls Alere Professional Urine Drug Controls with improper refrigeration causing misdiagnosis. Affected units may lead to incorrect test results if stored outside approved temperatures.
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Cardinal Health is recalling Alere Professional Urine Drug Controls that were stored outside the required refrigeration temperatures. This could cause misdiagnosis of drug tests, meaning results might be inaccurate.
The products require refrigeration to maintain accuracy. If stored outside the approved temperature range, the test results may be misdiagnosed, leading to incorrect conclusions about drug presence.
Healthcare providers using the Alere Professional Urine Drug Controls for drug testing are most at risk. Patients receiving these tests may get inaccurate results if the product was stored improperly.
Check for the product code 88010 with lot number KN00146. These Alere Professional Urine Drug Controls were sold with improper refrigeration conditions.
Verify if the product was stored outside the approved refrigeration temperature range.
The Alere Professional Urine Drug Controls were stored outside the required refrigeration temperatures, which may cause misdiagnosis of drug tests.
Check if the product was stored outside the approved refrigeration temperature range. If so, do not use it for testing.
The recall does not provide a specific fix; users must check storage conditions and avoid using the product if improperly stored.
We’ve drafted a message you can send Alere to request your refund or repair — edit it as you like.
Subject: Recall Z-2050-2020 — Alere Alere Hello, I own a Alere that is covered by recall Z-2050-2020 from Alere. 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.
