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Terminated

BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

FDA Recall Z-1977-2014 · Posted 2014-07-02

Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeOYE
Date Initiated2014-06-06
Date Terminated2015-01-27
Product Quantity35 installed devices

Reason for Recall

Laser cooling fans and internal fan of the associated fluidics cart are not operational.

Firm Action

BD sent an Important Product Recall notification letters dated June 2014 to affected US customers by trackable mail. International affiliates were notified on June 6, 2014. The letter identified the affected product, problem and the actions to be taken. A Field Change notification has been established and a BD field Service Engineer will coordinate with each account to perform the necessary corrections. Questions or concerns may be directed to BD Customer Support at BD Biosciences, prompt 2. Out of US customers are to contact local BD rep with questions.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.

Official Source

View FDA Recall →

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

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