Health product recall

Siemans Dimension Software Version 10.2.2 (2018-06-07)

Starting date:
June 7, 2018
Posting date:
September 7, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67682

Affected products

  1. Dimension Xpand System - Xpand Plus Basic Analyzer
  2. Dimension EXL System - Dimension EXL Analyzer With Loci Module
  3. Dimension Clinical Chemistry System - RxL Max Analyzer - Class 2
  4. Dimension Chemistry System - RxL Max Analyzer Class 3
  5. Dimension EXL System - Dimension EXL Analyzer With LM
  6. Dimension Xpand Plus Basic Analyzer - Class 2
  7. Dimension EXL System - Dimension EXL 200 Analyzer
  8. Dimension Xpand System - Xpand Plus With HM Analyzer - Class 2
  9. Imension Xpand System - Xpand Plus With HM Analyzer
  10. Dimension Chemistry System - Dimension RxL Max W/HM Analyzer

Reason

Siemens is informing users of the potential for intermittent failures with the group calibration feature in Dimension Software Version 10.2.2. A calibration may not auto accept when performing a group calibration with more than one Quality Control (QC) product. If all QC levels are not processed, Dimension QCC PowerPak auto acceptance for that calibration will not complete.

Affected products

A. Dimension Xpand System - Xpand Plus Basic Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

765000.921

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

B. Dimension EXL System - Dimension EXL Analyzer With Loci Module

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 759020.911
  • 778020.911
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

C. Dimension Clinical Chemistry System - RxL Max Analyzer - Class 2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 752000.901
  • 752000.951
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

D. Dimension Chemistry System - RxL Max Analyzer Class 3

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 752000.901
  • 752000.951
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

E. Dimension EXL System - Dimension EXL Analyzer With LM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 759020.911
  • 778020.911
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

F. Dimension Xpand Plus Basic Analyzer - Class 2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

765000.921

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

G. Dimension EXL System - Dimension EXL 200 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

778041.911

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

H. Dimension Xpand System - Xpand Plus With HM Analyzer - Class 2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

765000.931

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

I. Imension Xpand System - Xpand Plus With HM Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

765000.931

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

J. Dimension Chemistry System - Dimension RxL Max W/HM Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 752000.911
  • 752000.931-R
  • 752000.941
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES