FDA-Device2015-04-08Class II
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
BD Biosciences, Systems & Reagents
Hazard
The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.
Sold states
Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim
Affected count
72 devices
Manufactured in
2350 Qume Dr, N/A, San Jose, CA, United States
Products
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1370-2015Don't want to check this manually?
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