ADVIA Centaur System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay and ADVIA Centaur CP System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay (2017-12-21)
- Starting date:
- December 21, 2017
- Posting date:
- January 12, 2018
- 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-65654
Affected products
- ADVIA Centaur CP System - B-Type Natriuretic Peptide (BNP) Assay
- ADVIA Centaur System - B-Type Natriuretic Peptide (BNP) Assay
- ADVIA Centaur System - Tsh3-Ultra (Tsh3-Ul) Assay
- ADVIA Centaur CP System - Tsh3-Ultra (Tsh3-Ul) Assay
Reason
The ADVIA Centaur CP, XP and XPT systems will not expire the multi-diluent 15 pack at the end of the required 7-day on board stability (obs), if any of the affected B-type natriuretic peptide (BNP) or TSH3-UL lots are present on the system(s) when performing onboard dilutions. On the ADVIA Centaur XPT only, the system becomes inoperable under certain specific conditions.
Affected products
A. ADVIA Centaur CP System - B-Type Natriuretic Peptide (BNP) Assay
Lot or serial number
Kit Lot Ending: 192, 193, 196
Model or catalog number
- 02816138
- 02816634
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
B. ADVIA Centaur System - B-Type Natriuretic Peptide (BNP) Assay
Lot or serial number
Kit Lot Ending: 192, 193, 196
Model or catalog number
- 02816138
- 02816634
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
C. ADVIA Centaur System - Tsh3-Ultra (Tsh3-Ul) Assay
Lot or serial number
Kit Lot Ending: 298 & 301
Model or catalog number
- 06491072
- 06491080
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
D. ADVIA Centaur CP System - Tsh3-Ultra (Tsh3-Ul) Assay
Lot or serial number
Kit Lot Ending: 298 & 301
Model or catalog number
- 06491072
- 06491080
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES