Recall Z-2034-2012
Epocal Inc · initiated June 28, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Catalog #CT-1004-00-00, lot number 07-11087-00
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-2034-2012
- Initiated
- June 28, 2011
- Posted by FDA
- July 19, 2012
- Terminated
- December 18, 2013
- Product code
- CGA – Glucose Oxidase, Glucose
- Quantity
- 8,650
- Distribution
- US nationwide Distribution in the state of CA.
- Recalling firm
- Epocal Inc, Ottawa Canada, Ontario