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

    • 07-12283-00
    • 03/26/2013
    • 07-12284-00
    • 03/27/2013
    • 07-12285-00
    • 03/28/2013
    • 07-12289-00
    • 04/01/2013
    • 07-12290-00
    • 04/02/2013
    • 07-12292-00
    • 04/04/2013
    • 07-12293-00
    • 04/05/2013
    • 07-12296-00
    • 04/08/2013
    • 07-12297-00
    • 04/09/2013
    • 07-12298-00
    • 04/10/2013
    • 07-12300-00
    • 04/12/2013
    • 07-12303-00
    • 04/15/2013
    • 07-12305-00
    • 04/17/2013
    • 07-12306-00
    • 04/18/2013
    • 07-12307-00
    • 04/19/2013
    • 07-12310-00
    • 04/22/2013
    • 07-12312-00
    • 04/24/2013
    • 07-12313-00
    • 04/25/2013
    • 07-12314-00
    • 04/26/2013
    • 07-12317-00
    • 04/29/2013
    • 07-12320-00
    • 05/02/2013
    • 07-12321-00
    • 05/03/2013
    • 07-12324-00
    • 05/06/2013
    • 07-12325-00
    • 05/07/2013
    • 07-12327-00
    • 05/09/2013
    • 07-12331-00
    • 05/13/2013
    • 07-12333-00
    • 05/15/2013
    • 07-12335-00
    • 05/17/2013
    • 07-12338-00
    • 05/20/2013
    • 07-12340-00
    • 05/22/2013
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 31, 2016 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.