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FDANovember 14, 2019device

Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

abbott diabetes careabbottabbott diabetes

UPCs

00093815710653

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 — Recall Details · AllClear