Epocal Inc: Medical Device Recall in 2012 - (Recall #: Z-2034-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 28, 2011

Date Posted: July 25, 2012

Recall Number: Z-2034-2012

Event ID: 61147

Reason for Recall:

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.

Status: Terminated

Product Quantity: 8,650

Code Information:

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

Distribution Pattern:

US nationwide Distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated