Recall Z-1328-2009
Nova Biomedical Corporation · initiated August 11, 2008
Product
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 hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.
Codes / lots: Lots 806050, 806182, 806242, 806567, 806721, 806752, and 807246.
Reason for recall
Erroneous, low creatinine results on CCX analyzer
FDA-determined cause: Process control
Action taken
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 Notice by email and/or fax to the key customer contact from the initial phone contact. International - Sending the Customer Advisory Notice by email and/or fax to the key contact.
Details
- Recall number
- Z-1328-2009
- Initiated
- August 11, 2008
- Posted by FDA
- May 7, 2009
- Terminated
- July 22, 2011
- Product code
- CGL – Electrode, Ion Based, Enzymatic, Creatinine
- Quantity
- 1230
- Distribution
- Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.
- Recalling firm
- Nova Biomedical Corporation, Waltham, MA