ARCHITECT Rubella IgM Reagent Kit (2018-12-20)

Starting date:

December 20, 2018

Posting date:

January 23, 2019

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-68834

• 
  Reason
• 
  Affected products

Affected products

ARCHITECT Rubella IgM Reagent Kit

Reason

Abbott has identified that the incorrect components, 2 Assay diluent bottles (6C18J) or 2 pre-treatment bottles (6C18X), may be present in a portion of batch 90059FN00.

Kits that do not contain all correct components cannot be scanned on the architect instrument, an error code will be generated upon loading on the reagent inventory screen (e.g.: error code 0900 or 0201).

Affected products