Vitros Chemistry Products COCM Reagent (2013-10-04)

Starting date:

October 4, 2013

Posting date:

November 25, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36847

• 
  Reason
• 
  Affected products

Recalled products

A. Vitros Chemistry Products COCM Reagent 

Reason

OCD has received customer complaints of a downward drift/shift in quality control results or low quality control results when using Vitros chemistry products COCM reagent. This drift/shift will likely be observed within approximately 3-14 days of calibration. Patient results may be affected in the same manner. Our investigation has shown that recalibration will be initially effective in resolving the issue, but that increased calibration frequency may no longer be effective over time.

OCD internal testing has confirmed that this issue occurs will all lots of Vitros COCM reagent that are within expiration dating. As a result, customers are being asked to discontinue using and discard all Vitros COCM reagent remaining in their inventory.

Affected products