Z-2034-2012Class II

epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System

Name: Z-2034-2012 epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System
Creator: Epocal Inc
Published: 2011-06-28
License: https://open.fda.gov/license/

Epocal Inc / initiated 2011-06-28 / Terminated / root cause: design

FDA source

Epocal Inc began a recall of 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... on 2011-06-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2034-2012
Classification: Class II
Status: Terminated
Initiated: 2011-06-28
Posted: 2012-07-19
Terminated: 2013-12-18
Recalling firm: Epocal Inc
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
Product code: CGA Glucose Oxidase, Glucose
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.
Root cause tag: design
FDA root cause: Device Design
Action: Epocal Inc. sent a Voluntary Product Recall letter dated June 27, 2011 to the affected consignee. The letter identified the affected products, problem and actions to be taken. The letter ask that all products affected by this recall be sent back to Epocal and a replacement may be obtained. For questions call 1-613-738-6912.
Quantity in commerce: 8,650
Distribution: US nationwide Distribution in the state of CA.
Product codes and lots: Catalog #CT-1004-00-00, lot number 07-11087-00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2034-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2034-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19

Product code CGA

K090109Class IIBlood Gas, Electrolyte and Metabolite Test CardEpocal, Inc. / cleared 2009-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)