Recall Z-0112-2008 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Kroger meter, Omron HEA-214 meter, Optium Xido meter, Boots meter.
| Date | Feb 14, 2008 (initiated Aug 2, 2007) |
| Status | Terminated |
| Reason | Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display. |
| Root cause | Component design/selection |
| Action | Abbott sent Urgent Medical Device Correction letters, dated 31Aug07, to registered users/customers via FedEx or mail. The letter instructs users to verify that their display is correct, and if not, to discontinue use and call Abbott Customer Care at 1-877-844-4404 for a new meter. Warranty kits will have fliers added to them to alert users. Email and telephone contacts may be made as needed. U.S. consignees and registered users will be contacted by letter, telephone call or visit starting 23Aug07. Worldwide, customer lists will be |
| Quantity | 882,601 total meters distributed, 316,439 in the U.S. and 566,162 outside of the U.S. including Mexico and Canada |
| Distribution | Worldwide Distribution - USA, Canada, Mexico, Australia, Malaysia, Philippines, Germany, New Zealand, China, India, Singapore, Hong Kong, Taiwan, Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, Puerto Rico, Uruguay, Venezuela, and Japan. |
| FDA record | Open on fda.gov |