10
May
2017

Cl II AQUIOS CL Flow Cytometer

0

Company: Beckman Coulter Inc.
Date of Enforcement Report 5/10/2017
Class lI:

PRODUCT

AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV)
Recall Number Z-2035-2017

REASON
Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA on 4/3/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
188 units total (24 units in US)

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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