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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

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
Recall Number Z-2034-2012
Classification Class II
Code Info Catalog #CT-1004-00-00, lot number 07-11087-00
Product Distributed Qty 8,650
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.

Event Detail

Event Id 61147
Product Type Devices
Status Ongoing
Recalling Firm Epocal Inc
City Ottawa
State ON
Country CA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-06-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US nationwide Distribution in the state of CA.
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