FDAFDA · Food and drugs·Recall number Z-0855-2015
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Published December 31, 2014 · Recall initiated: November 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failure to submit a 510(k) for device labeling changes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Unistrip Technologies LLC
- Distributor
- US Distribution to the states of FL and OH.
- Lot
- U14030713, 814031313, U140312323, and U14031413.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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