Reported Jul 25, 2012 · Terminated
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood…
Epocal Inc.
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 Inc · 2060 Walkley Rd · Ottawa, Ontario · N/A
Is this the product you have?
- epoc Blood Analysis BGEM Test Cards for use with the epoc(R)
- Blood Analysis System Product UsageUsage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
- Lot codes and dates
Catalog #CT-1004-00-00lot number 07-11087-00
- Amount recalled
- 8,650
Where it was sold
- Nationwide
- CA
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.
This product could cause temporary or reversible health problems — stop using it.
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