FDA Device Recall Z-0162-2013: Siemens Healthcare Diagnostics, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0162-2013.

Recall Res Number

Z-0162-2013

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc

FEI Number

1219913

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-09-11

Date Posted

2012-10-28

Date Terminated

2016-09-01

Product Code

MOI

Event Number

63167

Product Quantity

15,455 kits

Product Description Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Reason for Recall BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

Action Details Siemens sent two "URGENT FIELD SAFETY NOTICE" letters dated August and September 2012 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was included for customers to complete and return.

Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.

Code Information / Serial Numbers BR Assay for CA 27.29 BR Assay Kit Lots ReadyPack¿ Lot Number Ending in 198:. 89291198,86469198,85752198,88939198, 87757198, 85459198, 88319198, 86295198, 85194198 ReadyPack¿ Lot Number Ending in 202: 93573202, 91045202, 93664202, 90880202, 93157202,91126202,90494202. BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots Lot Number Ending in 199: 87425199,85862199,86949199,85945199

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Fujirebio Diagnostics, Inc. Registration: 2521625 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
TOSOH CORP. Registration: 8031673 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration

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Medical Device Recall: Z-0162-2013

Recall Parameters & Description

Related Establishments / Registrations

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