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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

  1. Advia Centaur System - HIV Ag/Ab Combo (CHIV) Assays
  2. Advia Centaur XP - HIV Ag/Ab Combo (CHIV) Assay
  3. 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