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

FDA device recall Z-1971-2013 · posted 2013-08-14 · Terminated

Recall details

Recalling firm

Epocal

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CGA

Quantity affected

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,

Date initiated

2013-03-13

Date posted

2013-08-14

Date terminated

2016-08-31

Location

Ottawa Canada, Ontario

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