Recall Z-1783-2010 ยท CGA Glucose Oxidase, Glucose
Nova Biomedical Corporation
Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.
| Date | Jun 10, 2010 (initiated Feb 12, 2010) |
| Status | Terminated |
| Reason | Glucose strips report low glucose results |
| Root cause | Nonconforming Material/Component |
| Action | Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682. |
| Quantity | 392 Cases (1800 strips each) |
| Distribution | Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy. |
| FDA record | Open on fda.gov |