VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (2020-07-22)

Starting date:

July 22, 2020

Posting date:

August 28, 2020

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-73757

Last updated:
2020-08-28

• 
  Reason
• 
  Affected products

Affected products

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack

Reason

A VITROS Anti-SARS-CoV-2 Total Reagent Pack in which the reagent bottles were swapped within the reagent pack. If the two reagent bottles are switched in their positions, the correct reaction scheme is not followed for processing the assay. This can result in:

• False negative results for a sample that is reactive.
• Calibration failures, if the affected pack is used during calibration. This could lead to a delay in testing.
• Quality control failures for the reactive control, if the affected pack is used for testing quality control samples. This could lead to a delay in testing or releasing results.

Affected products