Recall Z-2006-2009 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Corp.
Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
| Date | Sep 16, 2009 (initiated Jun 10, 2009) |
| Status | Terminated |
| Reason | There may be a significant negative bias when testing neonate samples. |
| Root cause | Process control |
| Action | Roche Diagnostics notified consignees in the affected countries of the problem by "Urgent Field Safety Notice" dated June 10, 2009 and instructed to cease using the Accu-Chek Performa and Accu-Chek Inform II systems on neonates, except for systems using test strips with advanced chemistry. For questions and additional information, contact your local Roche Diagnostics sales affiliate or sales representative. |
| Quantity | 1,518 of total products |
| Distribution | International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070585 | ACCU-CHEK PERFORMA SYSTEM Roche Diagnostics Corp., May 25, 2007 |