Beckman Coulter recalls ISE Electrolyte Reference reagents with low pH that may cause false high patient CO2 results, delaying treatment. Affected units have specific lot numbers and UDI codes.
Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lead to delay in treatment.
Beckman Coulter is recalling electrolyte reference reagents that may cause false high CO2 results in patient tests, potentially delaying treatment. This affects lab tests for acid-base balance disorders.
The reagent has a low pH that can cause calibration failures and false high patient results. This may lead to delayed treatment for serious acid-base disorders.
Clinical laboratory users who test patient serum or plasma for CO2 levels. Those using the reagent for acid-base balance diagnosis are most at risk.
Check for lot number M909206 or UDI code 15099590202491 on the reagent container. The product is used for CO2 testing in human serum or plasma.
Look for lot number M909206 on the reagent container.
The reagent has a low pH that may cause CO2 calibration failures and false high patient results, potentially delaying treatment for acid-base disorders.
Check for lot number M909206 or UDI code 15099590202491 on the reagent container. The product is used for CO2 testing in human serum or plasma.
The recall record does not specify a remedy, so contact Beckman Coulter for guidance.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2136-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2136-2020 from Beckman Coulter. 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.
