Recall Z-2970-2020 ยท CGA Glucose Oxidase, Glucose
Siemens Healthcare Diagnostics Inc
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
| Date | Aug 28, 2020 |
| Status | Terminated |
| Reason | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia. |
| Root cause | Process control |
| Action | Siemens issued Urgent Medical Device Correction letter on August 28, 2020 via Federal Express stating the reason for recall communication letter informs customers of the issue and, health risk and action take: Please dispose any inventory of test card lot 01-20095-10 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or distributor office. Please review your inventory of these products and assess your laboratorys replacement needs. Please use epoc BGEM Test Card from another unaffec |
| Quantity | 463 boxes (50 test cards/box ) |
| Distribution | Nationwide Foreign: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200107 | epoc Blood Analysis System Epocal, Inc., Jun 5, 2020 |