Class 2 Device Recall EPOC BGE Test Card

• Date Initiated by Firm: October 16, 2008
• Date Posted: February 06, 2009
• Recall Status: Terminated on February 06, 2009
• Recall Number: Z-0952-2009
• Recall Event ID: 50209
• 510(K)Number: K061597
• Product Classification: Ion Specific Potassium Electrode - Product Code CEM
• Product: EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.
• Code Information: Lot number 00260
• FEI Number: 3004959793
• Recalling Firm/ Manufacturer: Epocal; 2935 Conroy Rd; Ottawa Canada
• For Additional Information Contact: Roy Layer; 613-738-6192 Ext. 258
• Manufacturer Reason for Recall: elevated range of potassium levels
• FDA Determined Cause: Other
• Action: The recalling firm visited the hospital on 10/18/08 to conduct an investigation. At the end of the visit, the firm representatives removed the remaining cards from the hospital and returned to the manufacturing location.
• Quantity in Commerce: 1000 test cards
• Distribution: Nationwide Distribution --- including state of CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CEM