epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Anal
FDA device recall Z-2034-2012 · posted 2012-07-19 · Terminated
Recall details
- Recalling firm
- Epocal Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 8,650
- Distribution
- US nationwide Distribution in the state of CA.
- Date initiated
- 2011-06-28
- Date posted
- 2012-07-19
- Date terminated
- 2013-12-18
- Location
- Ottawa Canada, Ontario
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD (K090109) | Epocal, Inc. | 2009-06-24 |