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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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