Reported Aug 21, 2013 · Terminated
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium…
Epocal
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Epocal · 2935 Conroy Rd · Ottawa, Ontario · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- LOT #'s EXP. DATES
100 of 100 codes
07-12283-0003/26/201307-12284-0003/27/201307-12285-0003/28/201307-12289-0004/01/201307-12290-0004/02/201307-12292-0004/04/201307-12293-0004/05/201307-12296-0004/08/201307-12297-0004/09/201307-12298-0004/10/201307-12300-0004/12/201307-12303-0004/15/201307-12305-0004/17/201307-12306-0004/18/201307-12307-0004/19/201307-12310-0004/22/201307-12312-0004/24/201307-12313-0004/25/201307-12314-0004/26/201307-12317-0004/29/201307-12320-0005/02/201307-12321-0005/03/201307-12324-0005/06/201307-12325-0005/07/201307-12327-0005/09/201307-12331-0005/13/201307-12333-0005/15/201307-12335-0005/17/201307-12338-0005/20/201307-12340-0005/22/2013
- LOT #'s EXP. DATES
- Amount recalled
- 828,750 Test Card
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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