Z-2034-2012 Class II Terminated
FDA device recall Z-2034-2012 was initiated by Epocal Inc on June 28, 2011 and is designated Class II. 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 t… The recall status is terminated (terminated December 18, 2013). Affected quantity: 8,650.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2012
- Initiation Date
- June 28, 2011
- Termination Date
- December 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,650
Product 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 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.
Distribution Pattern
US nationwide Distribution in the state of CA.
Code Information
Catalog #CT-1004-00-00, lot number 07-11087-00