Recall Z-1971-2013— Epocal
Class II · Terminated
Class II FDA medical device recall by Epocal, initiated 2013-03-13, terminated 2016-08-31. It names 2 FDA 510(k) clearances: K093297, K090109. 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.. Reason: 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..
- Recalling firm
- Epocal
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-13
- Terminated
- 2016-08-31
- Firm location
- Ottawa, Ontario, Canada
510(k) clearances named in this recall
2 on FDA's record- K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
- K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.