Recall Z-2034-2012 ยท CGA Glucose Oxidase, Glucose
Epocal Inc
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
| Date | Jul 19, 2012 (initiated Jun 28, 2011) |
| Status | Terminated |
| Reason | Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results. |
| Root cause | Device Design |
| Action | Epocal Inc. sent a Voluntary Product Recall letter dated June 27, 2011 to the affected consignee. The letter identified the affected products, problem and actions to be taken. The letter ask that all products affected by this recall be sent back to Epocal and a replacement may be obtained. For questions call 1-613-738-6912. |
| Quantity | 8,650 |
| Distribution | US nationwide Distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090109 | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD Epocal, Inc., Jun 24, 2009 |