FDA (Devices) recall action 84518
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.
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.
Roche Diabetes Care is recalling Accu-Chek Aviva test strips because they may fail to dose, potentially delaying blood glucose results and treatment decisions.
Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.