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).
Reported: May 10, 2017 Initiated: April 3, 2017 #Z-2035-2017
Product Description
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).
Reason for Recall
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 188 units total (24 units in US)
- Distribution
- Worldwide - US Nationwide in the countries of: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Kingdom and Zambia
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Beckman Coulter Inc.. Units affected: 188 units total (24 units in US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Moderate. Recall number: Z-2035-2017.
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