Recall Z-0004-2009 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes contr
| Date | Nov 21, 2008 (initiated Sep 19, 2008) |
| Status | Terminated |
| Reason | Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results. |
| Root cause | Process control |
| Action | Urgent: Medical Device Recall letters, dated 09/19/2008, were sent to consumer end users, direct account distributors and wholesalers, health care providers, and pharmacists notifying them of the recall. The letter states that if customers have strips from Lot 2829235, they should call LifeScan at 1-866-247-1281 and tell customer service that they have strips that need to be replaced. Customer service and QA scripts were provided to LifeScan staff to provide to any callers who inquire about the recall. The distributors and wholesalers were to locate and sequester any inventory from the affe |
| Quantity | 35308 vials |
| Distribution | Nationwide Distribution --- including Puerto Rico. |
| 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 |