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ARCHITECT "I" System - Anti-HBC II (Donor Screening and Cadaveric Testing) Reagent Kit (2015-02-26)
- Starting date:
- February 26, 2015
- Posting date:
- March 20, 2015
- 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-52615
Recalled Products
A) ARCHITECT "I" System - Anti-HBC II (Donor Screening & Cadaveric Testing) Reagent Kit
Reason
The ARCHITECT Anti-HBC II assay shows lower calibrator, control and sample RLU values, potentially leading to reduced specificity and increased false reactive results.
Affected products
A) ARCHITECT "I" System - Anti-HBC II (Donor Screening & Cadaveric Testing) Reagent Kit
Lot or serial number
42072LI00 Exp Date 2015-05-28
42072LI01Exp Date 2015-05-28
42253LI00 Exp Date 2015-06-30
42253LI01 Exp Date 2015-06-30
42255LI00 Exp Date 2015-06-30
42255LI01 Exp Date 2015-06-30
42256LI00 Exp Date 2015-06-30
Model or catalog number
8L44-25
8L44-30
8L44-35
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY