Recall Z-0715-03 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141.
| Date | Apr 9, 2003 (initiated Feb 12, 2003) |
| Status | Terminated |
| Reason | Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings. |
| Root cause | Other |
| Action | 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. |
| 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, Thailan |
| FDA record | Open on fda.gov |