Class 2 Device Recall PENTRA C200

• Date Initiated by Firm: October 10, 2012
• Date Posted: January 03, 2013
• Recall Status: Terminated on September 12, 2013
• Recall Number: Z-0633-2013
• Recall Event ID: 63838
• 510(K)Number: K103788
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• 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.
• Code Information: Lot number: 00456-4108
• Recalling Firm/ Manufacturer: Horiba Instruments, Inc dba Horiba Medical; 34 Bunsen; Irvine CA 92618-4210
• For Additional Information Contact: Kim Walker; 714-273-9254
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: Horiba Medical sent a Field Safety Notification and Acknowledgement Letter dated November 20, 2012, to all affected customers. The letter notified the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 calendar days via mail, email or fax. Customers with questions were instructed to contact their local representative. For questions regarding this recall call 714-273-9254.
• Quantity in Commerce: 384 units
• Distribution: Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE