Recall Z-2149-2014— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2149-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-23

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-06-23, terminated 2016-03-31. It names one FDA 510(k) clearance: K031038. Product: SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.. Reason: Complaints of failed calibration..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Terminated: 2016-03-31
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K031038 — ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYBayer Healthcare, LLC·cleared 2003-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

Reason for recall

Complaints of failed calibration.

Data sourced from openFDA. This site is unofficial and independent of the FDA.