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Architect System - Lipase Assay (2014-04-12)
- Starting date:
- April 12, 2014
- Posting date:
- April 30, 2014
- 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-39275
Recalled products
- Architect System - Lipase Assay
Reason
Package inserts for lipase reagent lots: 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11 have incorrect Smartwash parameters for triglyceride.
Affected products
A. Architect System - Lipase Assay
Lot or serial number
- 43819UQ03
- 43827UQ12
- 43994UQ07
- 44127UQ06
- 44334UQ07
- 44449UQ05
- 44596UQ08
- 44775UQ09
- 44930UQ11
Model or catalog number
- 7D80-31
Companies
- Manufacturer
-
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road,
Abbot Park
60064
Illinois
UNITED STATES