epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product U...
FDA Recall #Z-2034-2012 — Class II — June 28, 2011
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.
Recalling Firm
Epocal Inc — Ottawa, Ontario
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8,650
Distribution
US nationwide Distribution in the state of CA.
Code Information
Catalog #CT-1004-00-00, lot number 07-11087-00
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.