epoc Blood Analysis BGEM Test Cards for use with the recall
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…
Why was epoc Blood Analysis BGEM Test Cards for use with the 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog #CT-1004-00-00, lot number 07-11087-00
- 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…
- Recalling firm
- Epocal Inc
- Quantity
- 8,650
- Distribution
- US nationwide Distribution in the state of CA.
- Recall date
- July 25, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)