Health product recall

ARCHITECT Hemoglobin A1c (2017-12-21)

Starting date:
December 21, 2017
Posting date:
January 12, 2018
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-65672

Affected products

ARCHITECT Hemoglobin A1c

Reason

It was identified that interference from fetal hemoglobin (HbF) occurs at a level lower than what is stated in the ARCHITECT Hemoglobin A1c (ln 4p52-21) package insert. The package insert indicates that the Hemoglobin A1c (HbA1c) assay is susceptible to interference effects from HbF at > 20%, while the most current data shows interference at HbF at > 5%. All in-date lots of ln 4p52-21 reagent inventory are impacted.

Affected products

ARCHITECT Hemoglobin A1c

Lot or serial number
  • 50007UQ10
  • 50030UQ10
  • 50031UQ10
  • 50279UQ12
  • 50280UQ12
  • 50281UQ12
  • 50282UQ12
  • 50613UQ02
  • 50614UQ02
  • 50615UQ02
  • 50616UQ02
  • 50884UQ04
  • 51177UQ06
  • 51457UQ08
Model or catalog number

4P52-21

Companies
Manufacturer
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road
Abbott Park
60064
Illinois
UNITED STATES