FDA Device Recall Z-0081-2017: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0081-2017.

Recall Res Number

Z-0081-2017

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2432235

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-08-24

Date Posted

N/A

Date Terminated

2018-05-24

Product Code

LFX

Event Number

75037

Product Quantity

Foreign: 359 Kits

Product Description SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.

Reason for Recall Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.

Action Details Siemens sent an Urgent Medical Device Recall Letter IMC16-20.A.US , dated August 24, 2016, to the US consignees via FedEx, and an Urgent Field Safety Notice IMC16-20.A.OUS (dated August 2016) was sent to foreign representatives for distribution to foreign consignees. Customers were instructed to discontinue use of and discard the affected kit lots. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For questions, customers were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative.

Distribution Pattern Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries: Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.

Code Information / Serial Numbers Kit lots 0333 and 0334 (OUS)

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
Trinity Biotech USA Registration: 1318354 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ARLINGTON SCIENTIFIC, INC. Registration: 1641328 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
ZEUS SCIENTIFIC LLC Registration: 2242436 View Registration
PRINCETON BIOMEDITECH CORP. Registration: 2246703 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
DIAMOND DIAGNOSTICS Inc Registration: 3003030793 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
GOLD STANDARD DIAGNOSTICS, LLC Registration: 3007208259 View Registration
ABBOTT IRELAND Registration: 3008344661 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
BIOMERIEUX SA Registration: 8020790 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
BIO-RAD Registration: 8023060 View Registration
TOSOH CORP. Registration: 8031673 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
BIOMERIEUX ITALIA-INDUSTRIAL DIV. Registration: 9615037 View Registration

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Medical Device Recall: Z-0081-2017

Recall Parameters & Description

Related Establishments / Registrations

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