Device product
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.
Z-0633-2013
Product summary
- Event
- Event 63838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384 units
- Official record key
device-enforcement:Z-0633-2013
Official wording
Reason: 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.
Code information: Lot number: 00456-4108
Distribution pattern: Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Derived failure modes
-
Unknown
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.