Recall Z-1328-2009 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Nova Biomedical Corporation
Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobi
| Date | May 7, 2009 (initiated Aug 11, 2008) |
| Status | Terminated |
| Reason | Erroneous, low creatinine results on CCX analyzer |
| Root cause | Process control |
| Action | Initial: USA and Canada - Customer Advisory Notice notification by phone contact with key customer contact facilitated using a Field Correction Script. This contact will be documented within the Nova Biomedical Technical Support database (Pivotal) and on a Field Correction Checklist. All affected inventory will be replaced at customer sites. International - Customer Advisory Notice and Faxback Form being communicated and sent to Nova Biomedical Subsidiaries and Distributors by three methods of delivery (Email, Fax and Phone Call). Follow-up: USA and Canada - Sending the Customer Advisory Not |
| Quantity | 1230 |
| Distribution | Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022746 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER Nova Biomedical Corp., Nov 22, 2002 |