Z-1971-2013Class II

epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2...

Name: Z-1971-2013 epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2...
Creator: Epocal
Published: 2013-03-13
License: https://open.fda.gov/license/

Epocal Inc / initiated 2013-03-13 / Terminated / root cause: manufacturing process

FDA source

Epocal began a recall of epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate... on 2013-03-13. FDA classified it as Class II and gives the reason as "This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1971-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-13
Posted: 2013-08-14
Terminated: 2016-08-31
Recalling firm: Epocal Inc
Product: epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On March 13th 2013, Epocal placed all CT-1004-00-00 test card on shipment hold. Affected product in Epocal control has been segregated and quarantined. Beginning on March 26 2013, Epocal Inc. plans to begin distribution of the Recall Notification Letter to the 4 direct consignees (customers/distributors) via certified mail. Included with the Recall Notification Letter is a faxback verification form. Notification will include all distribution channels to the end-user level. Direct consignees are instructed to discontinue use and discard all stock on hand, complete the provided faxback verification form to document disposal and contact their consignees to advise them of the notification and disposal of affected product.
Quantity in commerce: 828,750 Test Card
Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia, US Virgin Islands and Puerto Rico, and the states of CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VE, WA, WI, and WV and the coutries of India, Argentina, Australia, Azerbaijan, Belarus, Canada, China, Colombia, Egypt, Germany, Guatemala, Israel, Japan, Malaysia, Mexico, Nepal, Netherlands, Peru, Philippines, Russia Fed., Singapore, South Africa, South korea, Thailand, and Vietnam.
Product codes and lots: LOT #'s EXP. DATES 07-12283-00 03/26/2013 07-12284-00 03/27/2013 07-12285-00 03/28/2013 07-12289-00 04/01/2013 07-12290-00 04/02/2013 07-12292-00 04/04/2013 07-12293-00 04/05/2013 07-12296-00 04/08/2013 07-12297-00 04/09/2013 07-12298-00 04/10/2013 07-12300-00 04/12/2013 07-12303-00 04/15/2013 07-12305-00 04/17/2013 07-12306-00 04/18/2013 07-12307-00 04/19/2013 07-12310-00 04/22/2013 07-12312-00 04/24/2013 07-12313-00 04/25/2013 07-12314-00 04/26/2013 07-12317-00 04/29/2013 07-12320-00 05/02/2013 07-12321-00 05/03/2013 07-12324-00 05/06/2013 07-12325-00 05/07/2013 07-12327-00 05/09/2013 07-12331-00 05/13/2013 07-12333-00 05/15/2013 07-12335-00 05/17/2013 07-12338-00 05/20/2013 07-12340-00 05/22/2013 07-12341-00 05/23/2013 07-12345-00 05/27/2013 07-12346-00 05/28/2013 07-12347-00 05/29/2013 07-12349-00 05/31/2013 07-12352-00 06/03/2013 07-12354-00 06/05/2013 07-12355-00 06/06/2013 07-12362-00 06/13/2013 07-12363-00 06/14/2013 07-13002-00 06/19/2013 07-13003-00 06/20/2013 07-13004-00 06/21/2013 07-13007-00 06/24/2013 07-13008-00 06/25/2013 07-13009-00 06/26/2013 07-13010-00 06/27/2013 07-13014-00 07/01/2013 07-13015-00 07/02/2013 07-13017-00 07/04/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1971-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1971-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14

Product code CGA

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)