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ADVIA Centaur Assays (2015-11-12)
- Starting date:
- November 12, 2015
- 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-56180
Affected Products
- Advia Centaur SYS-HIV AG/AB Combo Assay
-
ADVIA CENTAUR CP SYS-HIV AG/AB COMBO (CHIV) ASSAY
Reason
Siemens Healthcare Diagnostics has confirmed reports of calibration failures on the ADVIA Centaur HIV Ag/Ab Combo (CHIV) kit lots listed in section 1 due to imprecision of the low calibrator. An invalid calibration status will prevent CHIV results from being generated. Siemens has confirmed that due to sporadic aberrantly high relative light units (rlus), imprecision may be observed with the low calibrator, negative quality control (qc) material or negative samples.
Affected products
A. Advia Centaur SYS-HIV AG/AB Combo Assay
Lot or serial number
- 73544070
- 75980070
- 76675070
- 78024070
- 79139070
Model or catalog number
06520528
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA CENTAUR CP SYS-HIV AG/AB COMBO (CHIV) ASSAY
Lot or serial number
73544070
75980070
76675070
78024070
79139070
Model or catalog number
06520528
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES