Health product recall

ARCHITECT HAVAb-IgG and HAVAb-IgM Reagent Kit, and Alinity i HAVAb IgG Reagent Kit (2018-09-27)

Starting date:
September 27, 2018
Posting date:
October 26, 2018
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-68090

Affected products

  1. ARCHITECT HAVAb-IgG Reagent Kit
  2. ARCHITECT HAVAb-IgM Reagent Kit
  3. Alinity i HAVAb IgG Reagent Kit

Reason

Abbott has confirmed that a performance shift for the ARCHITECT HA V Ab-IgM, ARCHITECT HA V Ab-IgG and Alinity i HA VAb IgG reagent lots as listed in table has the potential to generate falsely elevated control and patient sample results. Preliminary investigation of this issue has identified a manufacturing error specific to the lots listed identified. Additional information will be provided upon completion of the investigation to help quantify the magnitude of the shift in results.

Affected products

A. ARCHITECT HAVAb-IgG Reagent Kit

Lot or serial number
  • 90356LI00
  • 90360LI00
Model or catalog number
  • 6C29-22
  • 6C29-27
Companies
Manufacturer
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY

B. ARCHITECT HAVAb-IgM Reagent Kit

Lot or serial number
  • 90227LI00
  • 90228LI00
  • 91012LI00
  • 91013LI00
Model or catalog number
  • 6C30-22
  • 6C30-27
Companies
Manufacturer
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY

C. Alinity i HAVAb IgG Reagent Kit

Lot or serial number
  • 90385LI00
Model or catalog number
  • 08P2632
Companies
Manufacturer
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY