24
Dec
2008

Cl Il Vidiera NsP Nucleic Sample Preparation

0

Company: Beckman Coulter Inc
Date of Enforcement Report 12/24/2008
Class:ll

PRODUCT
Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41, Recall # Z-0454-2009

REASON
Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the “Run Results” report.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea , CA , by telephone and letter on September 11, 2007.
Manufacturer: Beckman Coulter Inc., Fullerton , CA. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6 units

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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