Recall Z-0716-03 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
| 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 |
510(k) clearances named in this recall
| K982089 | ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS Boehringer Mannheim Corp., Sep 3, 1998 |