Recall Z-1381-06 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003.
| Date | Aug 11, 2006 (initiated Jun 27, 2006) |
| Status | Terminated |
| Reason | The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose results |
| Root cause | Other |
| Action | U.S. consignees, point of care coordinators or laboratory managers, long term care professionals, health care professionals, pharmacists, and mail order distributors were notified via letter dated 6/28/06 to cease using the strips and to contact the firm for replacement if they see loose beads in their vial. International accounts were also notified. |
| Quantity | 21,000,000 consumer vials and 10,000,000 hospital vials to U.S. plus 35,000,000 vials international-(Totals for Recalls |
| Distribution | Worldwide Distribution-USA and countries of Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Paraguay, Peru, Philippines, Singapore, South Africa, South Korea, Spain, Sweden, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.