BD Biosciences Cytometry Class II

Company: BD Biosciences,
Date of Enforcement Report 3/12/2008
Class:ll

PRODUCT
BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, Recall # Z-0570-2008

REASON
Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,136 units

DISTRIBUTION
Nationwide and Internationally

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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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