FDA Enforcement
Class II
Terminated
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.
Recall: Z-0633-2013
·
Reported January 9, 2013
Enforcement
- Recall Number
- Z-0633-2013
- Event ID
- 63838
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Horiba Instruments, Inc dba Horiba Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 9, 2013
- Initiation Date
- October 10, 2012
- Classification Date
- January 3, 2013
- Termination Date
- September 12, 2013
- Address
- 34 Bunsen, N/A, Irvine, CA, 92618-4210, United States
Description
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.
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 Info
Lot number: 00456-4108
Distribution
Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Quantity
384 units