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ADVIA CENTAUR CP SYSTEM ASSAY (2015-07-16)
- Starting date:
- July 16, 2015
- Posting date:
- July 29, 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-54456
Affected Products
A. ADVIA CENTAUR CP SYSTEM - CALIBRATOR A
B.ADVIA CENTAUR CP SYSTEM - T3 ASSAY
C.ADVIA CENTAUR CADVIA CENTAUR SYSTEM -T4 ASSAY
D.ADVIA CENTAUR SYSTEM - T3 ASSAY
E.ADVIA CENTAUR SYSTEM - T4 ASSAY
F.ADVIA CENTAUR SYSTEM - CALIBRATOR A
Reason
Siemens is issuing a customer notification for ADVIA centaur T4 assay for the manual 1:4 and 1:8 dilution recovery used on ADVIA Centaur and ADVIA Centaur CP Systems. Percent recoveries for 1:4 (with calibrator 'a' prior to lots ending in 87) and 1:8 (all lots) patient sample dilutions are lower than reported in the IFU. A similar shift between calibrator 'a' and the internal standardization for T3 assay was also identified.
Affected products
A. ADVIA CENTAUR CP SYSTEM - CALIBRATOR A
Lot or serial number
ALL UNEXPIRED LOTS
Model or catalog number
04800646
04800735
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
B.ADVIA CENTAUR CP SYSTEM - T3 ASSAY
Lot or serial number
38453
43789
ALL UNEXPIRED LOTS
Model or catalog number
04779663
04779671
04779779
04848169
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
C.ADVIA CENTAUR CADVIA CENTAUR SYSTEM -T4 ASSAY
Lot or serial number
ALL UNEXPIRED LOTS
Model or catalog number
110735
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
D.ADVIA CENTAUR SYSTEM - T3 ASSAY
Lot or serial number
38453
43789
ALL UNEXPIRED LOTS
Model or catalog number
04779663
04779671
04779779
04848169
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
E.ADVIA CENTAUR SYSTEM - T4 ASSAY
Lot or serial number
ALL UNEXPIRED LOTS
Model or catalog number
110735
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
F.ADVIA CENTAUR SYSTEM - CALIBRATOR
Lot or serial number
ALL UNEXPIRED LOTS
Model or catalog number
04800646
04800735
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES