Recall Z-0633-2013— Horiba Instruments, Inc dba Horiba Medical
Class II · Terminated
Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2012-10-10, terminated 2013-09-12. It names one FDA 510(k) clearance: K103788. 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.. 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..
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-10
- Terminated
- 2013-09-12
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.