Epocal: Medical Device Recall in 2013 - (Recall #: Z-1971-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 13, 2013

Date Posted: August 21, 2013

Recall Number: Z-1971-2013

Event ID: 65126

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.

Status: Terminated

Product Quantity: 828,750 Test Card

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated