Recall Z-1154-2013 ยท CGA Glucose Oxidase, Glucose
Nova Biomedical Corporation
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
| Date | Apr 19, 2013 (initiated Feb 25, 2013) |
| Status | Terminated |
| Reason | Glucose test strips reports no result message when tested |
| Root cause | Process design |
| Action | The firm, Nova Biomedical, sent an "Urgent Field Safety Notice 01-13SS" dated March 18, 2013 and US customers notification by phone contact and to the International customers including a Faxback Form to be communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). The customers were instructed to INVALIDATE the Nova StatStrip Glucose Test Strip lots indicated in the list on all StatStrip meters within your institute; REPLACE all Nova StatStrip Glucose Test Strips from the indicated lots with replacement test strips provided by Nova; REMOVE all unu |
| Quantity | 2200 cases |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM Nova Biomedical Corp., Jan 24, 2007 |