Recall Z-2034-2012— Epocal Inc

Name: FDA recall Z-2034-2012
Creator: U.S. Food and Drug Administration
Published: 2011-06-28

Class II · Terminated

Class II FDA medical device recall by Epocal Inc, initiated 2011-06-28, terminated 2013-12-18. It names one FDA 510(k) clearance: K090109. 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. 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..

Recalling firm: Epocal Inc
Classification: Class II
Status: Terminated
Initiated: 2011-06-28
Terminated: 2013-12-18
Firm location: Ottawa, Ontario, Canada

510(k) clearances named in this recall

1 on FDA's record

K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARDEpocal, Inc.·cleared 2009-06-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.