Recall Z-1042-2007 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)
| Date | Jul 13, 2007 (initiated Mar 22, 2007) |
| Status | Terminated |
| Reason | Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings. |
| Root cause | Other |
| Action | March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone. |
| Quantity | ~33 million vials (25 strips per vial in the US, ~19 million worldwide. |
| Distribution | Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada. |
| 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 |