Recall Z-0572-06 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001, 03360652080, 03051188003, 03620115003 and 04535235003 (All sold outside of the United States).
| Date | Feb 28, 2006 (initiated Feb 10, 2006) |
| Status | Terminated |
| Reason | There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings. |
| Root cause | Other |
| Action | Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users. |
| Distribution | Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010362 | ACCU-CHEK COMFORT CURVE TEST STRIP Roche Diagnostics Corp., Mar 7, 2001 |