Recall Z-1596-05 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
| Date | Sep 29, 2005 (initiated Nov 21, 2003) |
| Status | Terminated |
| Reason | LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L. |
| Root cause | Other |
| Action | Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner''s booklet. |
| Quantity | Approximately 572,000 units |
| Distribution | The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner''s Booklets between March 31, 2003 and October 3, 2003. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024194 | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS Lifescan, Inc., Feb 7, 2003 |