Beckman Coulter PK7300(R) Cl III

Company:Beckman Coulter Inc..
Date of Enforcement Report 8/2/2017
Class lII:

PRODUCT

Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers: N3209000 and N2007600y Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722.
Recall Number B-0741-2017

REASON
Beckman Coulter’s PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed..

RECALLING FIRM/MANUFACTURER
Bedkman Coulter, Brea, CA on 6/19/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
342 units

DISTRIBUTION
Nationwide and Internationally

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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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