FDA (Devices) recall action 84866
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Abbott is recalling Precision Xtra Blood Glucose & Ketone Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA and could lead to infection.
Abbott is recalling Optium EZ Blood Glucose Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA, posing a risk of infection.
Abbott is recalling FreeStyle Precision H meters because unapproved instructions for disinfection and multi-patient use may lead to infection.