Dimension Vista System - Pseudocholinesterase Assay (2015-05-14)

Starting date:

May 14, 2015

Posting date:

June 10, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53723

• 
  Reason
• 
  Affected products

Recalled Products

A. Dimension Vista System - Pseudocholinesterase Assay

Reason

Increase in frequency of absorbance errors [E141: IOD error] on patient samples with the dimension vista PCHE Flex reagent lots: 14147bc, 14160ba, 14168ab and 14198ac. The [E141: IOD error] flag is generated from an IOD (initial optical density) test value that is less than the software coded limit of 575. The IOD test calculation is used to monitor reagent delivery. Reagent that does not produce the typical colour may also generate lower than normal IOD test values, triggering the [E141: IOD error] flag. The issue does not affect every flex and not all well sets. Only patient samples with values close to the upper end of the assay range will be impacted and the absorbance error [E141: IOD error] flag are not reportable.

Affected products