epoc BGEM Test Card — Class II medical device recall Z-1971-2013

Terminated recall by Epocal, reported 2013-08-21, distributed nationwide. This recall is being initiated because the affected lots of this product may yield results that are not consis

Recall number	`Z-1971-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Epocal, Ottawa, Ontario, Canada
Recall initiated	2013-03-13
Classified	2013-08-14
Reported by FDA	2013-08-21
Terminated	2016-08-31
Distributed	Nationwide (US)
Countries outside the US	AR, AU, CA, CN, CO, DE, EG, GT, IL, IN, JP, KR, MX, MY, NL, NP, PE, PH, RU, SG, TH, VN, ZA
Quantity	828,750 test
Lot numbers	`07-12283-00`, `07-12284-00`, `07-12285-00`, `07-12289-00`, `07-12290-00`, `07-12292-00`, `07-12293-00`, `07-12296-00`, `07-12297-00`, `07-12298-00`, `07-12300-00`, `07-12303-00`, `07-12305-00`, `07-12306-00`, `07-12307-00`, `07-12310-00`, `07-12312-00`, `07-12313-00`, `07-12314-00`, `07-12317-00`, `07-12320-00`, `07-12321-00`, `07-12324-00`, `07-12325-00`, `07-12327-00`, `07-12331-00`, `07-12333-00`, `07-12335-00`, `07-12338-00`, `07-12340-00`, `07-12341-00`, `07-12345-00`, `07-12346-00`, `07-12347-00`, `07-12349-00`, `07-12352-00`, `07-12354-00`, `07-12355-00`, `07-12362-00`, `07-12363-00` and 10 more
Model numbers	`CT-1004-00-00`

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1971-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.