FDA-Device2013-01-09Class II
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
Horiba Instruments, Inc dba Horiba Medical
Hazard
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Sold states
Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Affected count
384 units
Manufactured in
34 Bunsen, N/A, Irvine, CA, United States
Products
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0633-2013Don't want to check this manually?
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