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
- Dimension Xpand System - Xpand Plus Basic Analyzer
- Dimension EXL System - Dimension EXL Analyzer With Loci Module
- Dimension Clinical Chemistry System - RxL Max Analyzer - Class 2
- Dimension Chemistry System - RxL Max Analyzer Class 3
- Dimension EXL System - Dimension EXL Analyzer With LM
- Dimension Xpand Plus Basic Analyzer - Class 2
- Dimension EXL System - Dimension EXL 200 Analyzer
- Dimension Xpand System - Xpand Plus With HM Analyzer - Class 2
- Imension Xpand System - Xpand Plus With HM Analyzer
- 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