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Terminated

AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.

FDA Recall Z-2900-2016 · Posted 2016-09-28

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeOYE
Date Initiated2016-09-06
Date Terminated2017-08-07
Product Quantity148 units total (12 units in US)

Reason for Recall

Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.

Firm Action

An Urgent Medical Device Recall letter dated 9/6/16 was sent to customers to inform them that the use of Positions 9 and 10 of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. The letter informs the customers of the impact of the recall, action to be taken, and the resolution by Beckman Coulter. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding this notice, are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support; call 1-800-369-0333 in the US and Canada; outside the US and Canada, contact their local Beckman Coulter Representative.

Root Cause

Software Design Change

Distribution Pattern

US: IL, PA, NY, GA, WA, FL, SC. Affected geographies: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Panama, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Uganda, United Kingdom and Zambia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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