Recall Z-0263-2007 ยท CGA Glucose Oxidase, Glucose
Milwaukee Notions, Inc
OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters.
| Date | Dec 16, 2006 (initiated Oct 10, 2006) |
| Status | Terminated |
| Reason | Counterfeit (manufacturer unknown) |
| Root cause | Other |
| Action | Firm started contacting pharmacists beginning 10/10/06. The phone call told the pharmacist that certain lots were identified by LifeScan as counterfeit and not to further distribute. Recontact on 10/27/2006 updated instructions to pharmacists to recall to the ''user/consumer'' level. |
| Quantity | 1,695 |
| Distribution | Nationwide distribution ---- including states of IL, KY, MA, MI, MN, NE, OH, PA, SD, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.