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U.S. Department of Health and Human Services

Class 2 Device Recall PENTRA C200

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  Class 2 Device Recall PENTRA C200 see related information
Date Initiated by Firm October 10, 2012
Date Posted January 03, 2013
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = HORIBA ABX SAS
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