Recall Z-0272-06 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter
| Date | Dec 8, 2005 (initiated Oct 10, 2005) |
| Status | Terminated |
| Reason | Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters |
| Root cause | Other |
| Action | A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit. |
| Quantity | 2843 kits |
| Distribution | Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., May 20, 2005 |