Dimension Xpand System - Xpand Plus Basic Analyzer (Class 2 and 3), Xpand Plus with HM Analyzer (Class 2 and 3) and Dimension EXL 200 Analyzer (2018-01-16)
- Starting date:
- January 16, 2018
- Posting date:
- February 1, 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-65876
Affected products
- DIMENSION XPAND SYSTEM - XPAND PLUS BASIC ANALYZER
- DIMENSION XPAND PLUS BASIC ANALYZER - class 2
- DIMENSION EXL 200 ANALYZER
- DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER - class 2
- DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER
Reason
Manufacturer identified an issue with Dimension Software version 10.2.1. The software version does not permit the user to enter or edit calibration coefficients for applicable assays without support from a Siemens customer service representative.
Affected products
A. DIMENSION XPAND SYSTEM - XPAND PLUS BASIC ANALYZER
Lot or serial number
2004081160
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 XPAND PLUS BASIC ANALYZER - class 2
Lot or serial number
2004081160
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
C. DIMENSION EXL 200 ANALYZER
Lot or serial number
DE270253
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
D. DIMENSION XPAND SYSTEM - XPAND PLUS with hm analyzer - class 2
Lot or serial number
2001081906
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
E. DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER
Lot or serial number
2001081906
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