epoc Blood Analysis BGEM Test Cards for use with the epoc — Class II medical device recall Z-2034-2012
Terminated recall by Epocal Inc, reported 2012-07-25, distributed nationwide. Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality con
| Recall number | Z-2034-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Epocal Inc, Ottawa, Ontario, Canada |
| Recall initiated | 2011-06-28 |
| Classified | 2012-07-19 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 8,650 |
| Lot numbers | 07-11087-00 |
| Model numbers | CT-1004-00-00 |
Product
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
Reason for recall
Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.
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-2034-2012. 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.