Recall Z-0724-2008 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Nova Biomedical Corporation
Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454
| Date | Feb 16, 2008 (initiated Nov 2, 2007) |
| Status | Terminated |
| Reason | Incorrect Results - Creatinine results were lower than the laboratory reference method. |
| Root cause | Device Design |
| Action | Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com. |
| Quantity | 133 units |
| Distribution | Nationwide Distribution, including the state of NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS Nova Biomedical Corp., May 7, 2007 |