Device 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
Z-2034-2012
Product summary
- Firm
- Epocal Inc
- Event
- Event 61147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,650
- Official record key
device-enforcement:Z-2034-2012
Official wording
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 information: Catalog #CT-1004-00-00, lot number 07-11087-00
Distribution pattern: US nationwide Distribution in the state of CA.
Derived failure modes
-
Unknown
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.