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Dimension Chemistry System and Calibrators (2015-09-18)
- Starting date:
- September 18, 2015
- Posting date:
- October 14, 2015
- 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-55344
Affected Products
- Dimension Clinical Chemistry System
- Dimension XPAND SYSTEM-Chemistry Calibrator
- Dimension EXL System - Chemistry Calibrator
Reason
The section of instructions for use relating to open product stability time incorrectly states "24 jours (days)." Please be advised that this should be listed as "24 heures (hours)" in accordance with the validated product stability claims.
Affected products
A. Dimension Clinical Chemistry System
Lot or serial number
All lots.
Model or catalog number
DC18C
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Alabama
UNITED STATES
B. Dimension XPAND SYSTEM-Chemistry Calibrator
Lot or serial number
All lots.
Model or catalog number
DC18C
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Alabama
UNITED STATES
C. Dimension EXL System - Chemistry Calibrator
Lot or serial number
All lots.
Model or catalog number
DC18C
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Alabama
UNITED STATES