Health product recall

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

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

ALINITY I HIV AG/AB COMBO CALIBRATOR

Lot or serial number

21292BE00

Model or catalog number

08P0701

Companies
Manufacturer
Abbott GmbH
Max Planck Ring 2
Wiesbaden
65205
GERMANY