Abbott Diabetes Care recalls Precision Xtra blood glucose and ketone meters with specific UDI numbers due to unapproved disinfection instructions that could cause infections if not handled properly.
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 Diabetes Care is recalling certain Precision Xtra blood glucose and ketone meters because their disinfection instructions were not approved by the FDA. This could lead to improper cleaning and increase infection risk for users.
The meters were not cleared by the FDA for multiple-patient use, and the disinfection instructions could lead to improper cleaning. This might cause infections or worsen existing infections if contaminated meters are not handled correctly.
People who own or use the recalled Precision Xtra blood glucose and ketone meters with the specific UDI numbers listed are affected. Those with diabetes who test blood glucose or ketones regularly are most at risk.
Check the unique device identifier (UDI) on the meters. The recalled units have UDI numbers 00093815715023 and 00093815988144. The product is not associated with specific model or lot numbers.
Look for the unique device identifier (UDI) on the meter to confirm if it matches the recalled numbers 00093815715023 or 00093815988144.
The disinfection instructions for the meters were not approved by the FDA for multiple-patient use, which could lead to improper cleaning and infection risks.
Check the unique device identifier (UDI) on the meter. Recalled units have UDI numbers 00093815715023 or 00093815988144.
The recall does not require immediate stoppage; however, you should check the UDI to confirm if your meter is affected.
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-1556-2020 — Abbott Diabetes Care Abbott Diabetes Care Hello, I own a Abbott Diabetes Care that is covered by recall Z-1556-2020 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.
