ARCHITECT B12 Reagent Kit (2018-12-20)
- Starting date:
- December 20, 2018
- Posting date:
- January 10, 2019
- 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-68716
Affected products
ARCHITECT B12 Reagent Kit
Reason
Abbott has identified that the incorrect components, 2 assay diluent bottles (7K61J) or 2 pre-treatment 1 bottles (7K61U), may be present in a portion of batch 91345UI00. Kits that do not contain all correct components cannot be scanned on the architect instrument, an error code will be generated upon loading on the reagent inventory screen (e.g.: error code 0900 or 0201).
Affected products
ARCHITECT B12 Reagent Kit
Lot or serial number
91345UI00
Model or catalog number
7K61-35
Companies
- Manufacturer
-
Abbott Ireland Diagnostic Division
Lisnamuck, Longford
IRELAND