Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
This recall has been terminated (originally issued April 9, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- February 12, 2003
- Posted
- April 9, 2003
- Terminated
- September 15, 2003
- Recall Number
- Z-0716-03
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
Distribution
United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.
Lot / Code Info
All lots.
Root Cause
Other
Action Taken
Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.