The Recall Desk
HighFDA (Devices)·Z-2034-2012·Announced 2012-07-25

Epocal Recalls BGEM Test Cards for Potential Low Glucose Results

Epocal Inc is recalling 8,650 epoc Blood Analysis BGEM Test Cards because a portion of the lot may report inaccurate low glucose results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may provide inaccurate diagnostic results (low glucose), which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Epocal Inc is recalling 8,650 units of epoc Blood Analysis BGEM Test Cards, catalog number CT-1004-00-00, lot number 07-11087-00. These test cards are used with the epoc(R) Blood Analysis System, a point-of-care testing device.

The recall was initiated after a customer reported quality control issues during the incoming inspection of a newly received lot. Further investigation by Epocal determined that approximately 3,000 cards from this specific lot could potentially report low glucose results.

The affected products were distributed nationwide in the United States, including the state of California. Users of the epoc Blood Analysis System should check their inventory for the specific lot number and stop using the affected test cards.

The recalled product

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
Epocal Inc
Category
Medical Device — Point-of-Care Testing
Hazard
Affected units
8,650

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog #CT-1004-00-00
  • lot number 07-11087-00

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · inaccurate diagnostic

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