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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