FDA Device Recall Z-0128-2015: Siemens Healthcare Diagnostics, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0128-2015.

Recall Res Number

Z-0128-2015

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc

FEI Number

1219913

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-10-09

Date Posted

2014-10-24

Date Terminated

2015-06-18

Product Code

DBF

Event Number

69449

Product Quantity

8263 kits

Product Description ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

Reason for Recall Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system

Action Details Siemens issued an Urgent Field Safety Notice via e-mail to all US customers affected on October 9, 2012. This notice informs the customer of the Field Correction and the actions that need to be taken. The Urgent Field Safety Notice instructs customers that upon receipt of Calibrator C Lots ending in 25 and higher (Cal C lots CC25LA and higher and Cal C lots CC25HA and higher), discontinue use of the Calibrator C lots ending in 22 and 23 with the ADVIA Centaur Ferritin assay when used on the ADVIA Centaur CP system. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Further questions please call (508) 668-5000

Distribution Pattern Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.

Code Information / Serial Numbers Lot numbers: 82052A22 Exp Date 01/19/2013 82335A22 82909A22 85268A22 86701B22 88921B22 89956B22 90925B22 91336B22 95231A23 Exp. Date: 01/16/2013 95553A23

Related Establishments / Registrations

Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
CTK BIOTECH, INC. Registration: 2032682 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
KAMIYA BIOMEDICAL COMPANY LLC Registration: 2084025 View Registration
ALFA WASSERMANN Registration: 2247288 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
DENKA CO., LTD. Registration: 3003871639 View Registration
DiaSorin Deutschland GmbH Registration: 3004434309 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
ACRO BIOTECH Inc. Registration: 3005360469 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
IDS CO, LTD Registration: 3005655287 View Registration
LUMIQUICK DIAGNOSTICS, INC. Registration: 3005984081 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Beckman Coulter Biomedical GmbH Registration: 3006677029 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Kikuyo Factory Registration: 3015969360 View Registration
KENT LABORATORIES, INC. Registration: 3019906 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
TOSOH CORP. Registration: 8031673 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

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Medical Device Recall: Z-0128-2015

Recall Parameters & Description

Related Establishments / Registrations

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