Vitros Chemistry Products HPT Reagent

Starting date:

November 2, 2012

Posting date:

November 26, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-15894

• 
  Reason
• 
  Affected products

Recalled Products

1. Vitros Chemistry Products HPT Reagent

Reason

Ortho Clinical Diagnostic (OCD) has received complaints of the inability to calibrate the Vitros Chemistry products HPT reagent. OCD has also received reports of an increase in U91-274 condition codes. Although all affected lots met all release testing specifications prior to distribution, an OCD investigation has confirmed an increased occurrence of condition codes and calibration failures when using these lots over a period of time. OCD testing has found that as the reagent ages, a potential for biased results exists if you are able to obtain a valid calibration.

Affected products