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Dimension Systems Reagent Cartridges (2013-11-20)
- Starting date:
- November 20, 2013
- Posting date:
- January 6, 2014
- 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-37311
Recalled products
- Dimension Chemistry System - PBNP Flex Reagent Cartridge
- Dimension Xpand System - PBNP Flex Reagent Cartridge
Reason
Siemens is advising customers of a change in QC values for the Thermo Scientific mas Cardioimmune XL control lot 1601 level 1. The manufacturer of the controls notified siemens of changes to the control product after the QC values were published, and as a consequence, the values provided with the Dimension N-Terminal Pro-Brain Natriuretic Peptide flex reagent lots GA4210, FC4168, FA4098 and FA4224 require revision.
Affected products
A. Dimension Chemistry System - PBNP Flex Reagent Cartridge
Lot or serial number
- FA4098
- FA4224
- FB4098
- FB4224
- FC4168
- FD4168
- GA4210
- GB4210
Model or catalog number
- RF423A
- RF523A
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
B. Dimension Xpand System - PBNP Flex Reagent Cartridge
Lot or serial number
- FA4098
- FA4224
- FB4098
- FB4224
- FC4168
- FD4168
- GA4210
- GB4210
Model or catalog number
- RF423A
- RF523A
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES