Recall Z-0229-2015— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0229-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-06

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-10-06, terminated 2015-07-22. It names one FDA 510(k) clearance: K031038. Product: ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test). Reason: Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class III
Status: Terminated
Initiated: 2014-10-06
Terminated: 2015-07-22
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

ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)

Reason for recall

Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.

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