FDA-Device2012-07-25Class II
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
Epocal Inc
Hazard
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.
Sold states
US nationwide Distribution in the state of CA.
Affected count
8,650
Manufactured in
2060 Walkley Rd, Ottawa, Ontario, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2034-2012Don't want to check this manually?
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