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Health product recall

Dimension Chemistry System, Dimension Clinical Chemistry System, Dimension EXL System and Dimension XPAND System (2014-07-11)

Starting date:
July 11, 2014
Posting date:
August 1, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40755

Recalled Products

A) Dimension Chemistry System-RXL analyzer

B) Dimension Clinical Chemistry System-XL analyzer

C) Dimension Clinical Chemistry System –RXL analyzer

D) Dimension Chemistry System - XL analyzer

E) Dimension Clinical Chemistry System –RXL Max Analyzer

F) Dimension EXL System-Dimension EXL Analyzer (Licence #  78489)

G) Dimension EXL System-Dimension EXL Analyzer (Licence # 78489)

H) Dimension XPAND System-Dimension XPAND HM Analyzer

I) Dimension Clinical Chemistry System - RXL Max Analyzer (Licence # 2232)

J)  Dimension Clinical Chemistry System - RXL Max Analyzer (Licence # 7757)

K) Dimension EXL System-Dimension EXL Analyzer (Licence # 79670)

L) Dimension EXL System -Dimension EXL- LM Analyzer

M) Dimension EXL System -Dimension EXL 200 Analyzer

N)  Dimension XPAND System-Dimension XPAND HM

O) Dimension XPAND System - Dimension XPAND plus HM (Licence # 30615)

P) Dimension XPAND System - Dimension XPAND plus HM (Licence # 33405)

Reason

Siemens Healthcare Diagnostics has received complaints of QC and patient sample result accuracy shifts on CTNI (RF421C), LTNI (RF521C), FT4 (RF410), TSH (RF412), PBNP (RF423A) and LPBN (RF523A) when using dimension chemistry wash lot RD41041 on the dimension chemistry analyzers listed above. Internal investigation has confirmed bacterial contamination in chemistry wash lot RD41041.

Affected products

A) Dimension Chemistry System-RXL analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

756000901

756010.501

756010.912

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



B) Dimension Clinical Chemistry System-XL analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

750300.501

756000902

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



C) Dimension Clinical Chemistry System –RXL analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

756000901

756010.912

756010901

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



D) Dimension Chemistry System - XL analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

756000902

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



E) Dimension Clinical Chemistry System –RXL Max Analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

752000.931-R

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



F) Dimension EXL System-Dimension EXL Analyzer (Licence #  78489)

 

Lot or serial number

All serial numbers

Model or catalog number

778000.941

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



G) Dimension EXL System-Dimension EXL Analyzer (Licence # 78489)

 

Lot or serial number

All serial numbers

Model or catalog number

778021.911

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



H) Dimension XPAND System-Dimension XPAND HM Analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

766000.511

766000.931

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



I) Dimension Clinical Chemistry System - RXL Max Analyzer (Licence # 2232)

 

Lot or serial number

All serial numbers

Model or catalog number

752000.921

752000.931

752000.951

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



J)  Dimension Clinical Chemistry System - RXL Max Analyzer (Licence # 7757)

 

Lot or serial number

All serial numbers

Model or catalog number

752000.921

752000.931

752000.951

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



K) Dimension EXL System-Dimension EXL Analyzer (Licence # 79670)

 

Lot or serial number

All serial numbers

Model or catalog number

10459239

778000.941

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



L) Dimension EXL System -Dimension EXL- LM Analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

778021.911

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



M) Dimension EXL System -Dimension EXL 200 Analyzer

 

Lot or serial number

All serial numbers

Model or catalog number

778041.931

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



N)  Dimension XPAND System-Dimension XPAND HM

 

Lot or serial number

All serial numbers

Model or catalog number

766000.931

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



O) Dimension XPAND System - Dimension XPAND plus HM (Licence # 30615)

 

Lot or serial number

All serial numbers

Model or catalog number

765000.931

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



P) Dimension XPAND System - Dimension XPAND plus HM (Licence # 33405)

Lot or serial number

All serial numbers

Model or catalog number

765000.931

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


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