Vitros Chemistry Products (2013-10-18)

Starting date:

October 18, 2013

Posting date:

November 29, 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-36879

• 
  Reason
• 
  Affected products

Recalled Products

A. Vitros Chemistry Products Sodium Slides (NA+)

B. Vitros Chemistry Products Calibrator Kit 2

Reason

OCD has confirmed that positively biased serum or plasma sample results may occur when using Vitros NA+ slides, Gens 7-13. Our data determined that the largest bias was observed when using slides from Gens 7-13 when calibrated with Vitros calibrator kit 2, lots 212 and 292. The amount of bias is dependent upon multiple sources of variability that include but are not limited to the slide gen, calibrator kit lot, calibration event and Vitros system. It is important to note that not all combinations of Vitros NA+ slide Gens and calibrator kit lots resulted in biased NA+ results.

Customers may continue to use their remaining inventory of Gens 7-13 providing the following criteria are met:/p>

1. calibration is successful
2. quality control results are within the established range of means/acceptable limits.
3. distribution of normal results for serum or plasma samples are centered within the established reference interval for their laboratory.

Affected products