Abbott recalls FreeStyle Precision H blood glucose and ketone meters 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 is recalling FreeStyle Precision H blood glucose and ketone meters because their disinfection instructions were not approved by the FDA. This could lead to infections if users improperly clean the meters or handle contaminated devices.
The meters were not cleared for multiple-patient use, and the disinfection instructions were not approved by the FDA. Improper cleaning or handling could lead to infections or worsen existing infections.
People who use FreeStyle Precision H blood glucose and ketone meters for diabetes management are affected. Those with compromised immune systems or existing infections are at higher risk.
Check for the unique device identifier (UDI) 00093815711810 on the meters. All lots of this specific model are affected.
Check if you have the unapproved disinfection instructions for the FreeStyle Precision H meters.
Reach out to Abbott Diabetes Care for specific advice on safe handling and disinfection.
The disinfection instructions were not approved by the FDA and could lead to infections if meters are not handled properly.
Check for the unique device identifier (UDI) 00093815711810 on the meters. All lots of this specific model are affected.
Review the disinfection instructions and contact Abbott Diabetes Care for guidance on safe handling.
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-1558-2020 — Abbott Diabetes Care Abbott Diabetes Care Hello, I own a Abbott Diabetes Care that is covered by recall Z-1558-2020 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.
