FDA (Devices) recall action 64478
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
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.
LifeScan Inc is recalling OneTouch Ultra Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.
Lifescan Inc is recalling OneTouch Select Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.