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Epocal Inc recalls epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blo
Recalled July 25, 2012 · FDA recall Z-2034-2012 · Epocal
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. · FDA Class II
Units
8,650
Sold at
US nationwide Distribution in the state of CA.
Description
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.
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
Manufacturer(s)
Epocal Inc
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →