FDAFDA · Food and drugs·Recall number Z-2034-2012
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
Published July 25, 2012 · Recall initiated: June 28, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Epocal Inc
- Distributor
- US nationwide Distribution in the state of CA.
- Lot
- Catalog #CT-1004-00-00, lot number 07-11087-00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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