This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Advia Centaur Systems - HIV Ag/Ab Combo (CHIV) Assays (2013-09-17)
- Starting date:
- September 17, 2013
- Posting date:
- October 17, 2013
- 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-36261
Recalled products
- Advia Centaur System - HIV Ag/Ab Combo (CHIV) Assays
- Advia Centaur XP - HIV Ag/Ab Combo (CHIV) Assay
- Advia Centaur CP - HIV Ag/Ab Combo (CHIV) Assay
Reason
The analytical sensitivity statements in the Advia Centaur / XP and Advia Centaur CP IFUs were based on one lot of reagent. Siemens evaluated the current P24 analytical sensitivity with multiple lots to determine if the HIV Ag / Ab combo (CHIV) assay is meeting the IFU statements. Five out of the seven lots evaluated on the Advia Centaur / XP and four out of seven lots evaluated on the Advia Centaur CP did not meet the statement in the IFU with regard to P24 analytical sensitivity. However, the CHIV assay is meeting the design requirements (Dir target < 1.5 IU/mL, Dir minimum < 2.0 IU/ml) and the CTS analytical sensitivity requirement of less than and equal to 2.0 IU/mL.
Affected products
A. Advia Centaur System - HIV Ag/Ab Combo (CHIV) Assays
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 06520528
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia Centaur XP - HIV Ag/Ab Combo (CHIV) Assay
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 06520528
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
C. Advia Centaur CP - HIV Ag/Ab Combo (CHIV) Assay
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 06520528
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES