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U.S. Department of Health and Human Services

Class 2 Device Recall EPOC BGE Test Card

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  Class 2 Device Recall EPOC BGE Test Card see related information
Date Initiated by Firm October 16, 2008
Date Posted February 06, 2009
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = EPOCAL, INC.
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