Recall Z-2639-2010 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
| Date | Oct 1, 2010 (initiated Jan 7, 2010) |
| Status | Terminated |
| Reason | One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips. |
| Root cause | Mixed-up of materials/components |
| Action | Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product. |
| Quantity | 9631 cartons, 4 vials per carton |
| Distribution | Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., Aug 16, 2006 |