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