FDA Enforcement
Class II
Terminated
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
Recall: Z-2034-2012
·
Reported July 25, 2012
Enforcement
- Recall Number
- Z-2034-2012
- Event ID
- 61147
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Epocal Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 25, 2012
- Initiation Date
- June 28, 2011
- Classification Date
- July 19, 2012
- Termination Date
- December 18, 2013
- Address
- 2060 Walkley Rd, Ottawa, Ontario, N/A, Canada
Description
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
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.
Code Info
Catalog #CT-1004-00-00, lot number 07-11087-00
Distribution
US nationwide Distribution in the state of CA.
Quantity
8,650