Device evidence

device-recall:cfres:123985

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.

Official recall number

Z-0486-2014

Evidence summary

Product code: NBW
Recall status: Terminated
Event initiated: November 18, 2013
Root cause: Other
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0486-2014