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Advia Centaur CP and XP System-B-type Natriuretic Peptide (BNP) assay and Advia Centaur System-B-type Natriuretic Peptide (BNP) assay (2014-10-08)

Starting date:
October 8, 2014
Posting date:
October 22, 2014
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-41865

Recalled Products

A) Advia Centaur CP System-B-type Natriuretic Peptide (BNP) assay
B) Advia Centaur XP System-B-type Natriuretic Peptide (BNP) assay
C) Advia Centaur System-B-type Natriuretic Peptide (BNP) assay

Reason

There may be an incorrect side label on a small percentage of the Advia Centaur Systems BNP ready packs from reagent lot 038174. Incorrectly labeled ready packs are included within kit lots 43305174, 43278174, 43306174 and 43279174. The human-readable side label may incorrectly identify the ready pack as Advia Centaur Systems FT4 ready pack. The ready pack end label and the barcode end label correctly identify the ready pack as the Advia Centaur Systems BNP ready pack and the ready pack will scan correctly as BNP when loaded onto the Advia Centaur Systems. The kit boxes are correctly labeled as BNP. Other Advia Centaur BNP kit lots ending in 174 are not impacted.

Affected products

A) Advia Centaur CP System-B-type Natriuretic Peptide (BNP) assay

Lot or serial number

43278174
43279174
43305174
43306174

Model or catalog number

02816138
02816634

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES

B) Advia Centaur XP System-B-type Natriuretic Peptide (BNP) assay
 

Lot or serial number

43278174
43279174
43305174
43306174

Model or catalog number

02816138
02816634

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES

C) Advia Centaur System-B-type Natriuretic Peptide (BNP) assay

Lot or serial number

43278174
43279174
43305174
43306174

Model or catalog number

02816138
02816634

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES