Z-0486-2014 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- November 18, 2013
- Termination Date
- August 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141,219 cartons for human use - total
Product Description
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Reason for Recall
Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.
Distribution Pattern
Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**
Code Information
Part number: 71026-70; Lot number: 1281732; Exp. date: 2014/05; Lot number: 1283603; Exp. date: 2014/06; Part number: 70827-71: Lot number: 1363015, Exp. Date: 2014/11; Lot number: 1363109, Exp. Date 2014/11: Lot number: 1365921, Exp. Date 2014/12; Part number 70827-72: Lot number: 1366006 Exp. Date : 2014/12; Lot number 1366111, Exp. Date: 2014/12; Lot number 1366337; Exp. Date: 2014/12; Lot number: 1366515, Exp Date: 2014/12; Part number 70822-71; Lot number 1283345: Exp. Date: 2014/05; Lot number 1365920; Exp. Date: 2014/12; Lot number 1365934; Exp. Date: 2014/12; Part number: 70822-72: Lot number: 1350414: Exp Date: 2014/07; Lot number 1363321; Exp. Date 2014/11: Part number: 70819-70: Lot Number: 1365056: Exp. Date 2014/11; Lot number: 1366347: Exp. Date: 2014/12; Lot number: 1367917; Exp. Date 2014/12 Lot number: 1374907; Exp. Date 2015/03.