Abbott recalls Optium EZ glucose meters due to unapproved disinfection instructions that could cause infections if not handled properly. Affected units lack FDA clearance for multiple-patient use.
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Abbott is recalling Optium EZ blood glucose meters because their disinfection instructions were not approved by the FDA. This could lead to infections if the meters are not handled correctly, especially when used by multiple patients.
The meters were not cleared by the FDA for multiple-patient use. Improper disinfection following unapproved instructions could lead to infections or worsen existing infections.
People with diabetes who use Optium EZ glucose meters are affected. Those using the meters for multiple patients are at higher risk of infection.
Check for the unique identifier (UDI) 00093815710653 on the Optium EZ glucose meters. The recall does not specify model or lot numbers beyond this UDI.
Look for the unique identifier (UDI) 00093815710653 on the device.
The disinfection instructions for these meters were not approved by the FDA and could lead to infections if not handled properly.
The recall specifies only the UDI 00093815710653; no other model or lot numbers are listed.
The recall does not provide a safe usage condition; the meters were not cleared for multiple-patient use.
We’ve drafted a message you can send Abbott Diabetes Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1557-2020 — Abbott Diabetes Care Abbott Diabetes Care Hello, I own a Abbott Diabetes Care that is covered by recall Z-1557-2020 from Abbott Diabetes Care. 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.
