FDA (Devices) recall action 98049
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
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.
Abbott Diabetes Care is recalling 1,663,241 FreeStyle Libre 3 Plus sensors, REF 78768-01, because carbon build up in the sensor may result in incorrect low glucose results.
Abbott Diabetes Care is recalling 1,060,723 FreeStyle Libre 3 sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.
Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.
Abbott Diabetes Care is recalling 258,913 FreeStyle Libre 3 Plus sensors, REF 78769-01, because carbon build up in the sensor may result in incorrect low glucose results.