ALINITY I HIV AG/AB COMBO CALIBRATOR (2021-02-10)

Starting date:

February 10, 2021

Posting date:

February 19, 2021

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-75019

Last updated:
2021-02-19

• 
  Reason
• 
  Affected products

Affected Products 

ALINITY I HIV AG/AB COMBO CALIBRATOR

Reason

Abbott identified internally a manufacturing issue where individual vials of the Alinity i HAVAb IgG Calibrator were mislabeled as Alinity i HIV Ag/Ab Combo Calibrator lot number 21292BE00.

Impacted vials can cause invalid calibrations due to low RLU (Relative Light Units) calibrator signals. When calibrating using an impacted vial you will observe either:

• Message code: 1400: Calibration failed for assay (HIV Ag/Ab) number (396). (CV too large for Cal 1).
• Or, if a calibration passes, the quality control values will be out of specification high and the calibrations are invalid.

Affected products