epoc Blood Analysis BGEM Test Cards for use with the… recallZ-2034-2012 · Epocal Inc · initiated Jun 28, 2011
Class II Terminated All recalls posted in July 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Epocal Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
Epocal Inc. sent a Voluntary Product Recall letter dated June 27, 2011 to the affected consignee. The letter identified the affected products, problem and actions to be taken. The letter ask that all products affected by this recall be sent back to Epocal and a replacement may be obtained. For questions call 1-613-738-6912.
Recall details
- Recall number
- Z-2034-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 28, 2011
- Posted by the FDA
- Jul 19, 2012
- Recalling firm
- Epocal Inc
- Quantity
- 8,650
- Product code
- CGA
- FDA submissions
- K090109
- Distribution
- US nationwide Distribution in the state of CA.
Product description
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
Code information (models, lots, serial numbers)
Catalog #CT-1004-00-00, lot number 07-11087-00
Other devices under the same FDA submission
1 device cleared under K090109 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- epoc Host2 11413524Epocal Inc · ELECTRODE, ION SPECIFIC, CALCIUM1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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