Day

October 17, 2012
Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the...
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Company:Sunquest Information Systems, Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT Sunquest Laboratory. Sunquest Application Interfacing Outbound Department of Health Interface. Recall Number B-2584-12 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tuscon, AZ on 12/14/2009. Voluntary: Firm Initiated recall was terminated. VOLUME OF PRODUCT IN COMMERCE...
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A new version of EN 14971 was published and harmonized in the Official Journal of the EU. ISO 14971 now may not ensure compliance with EU essential requirements for medical devices. Specifically, 14971 allows the manufacturer to disregard negligible risks; but all risks must be taken into account and reduced as much as possible to...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide...
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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