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U.S. Department of Health and Human Services

Class 2 Device Recall ABX PENTRA AST CP,

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 Class 2 Recall
ABX PENTRA AST CP,
see related information
Date Posted January 03, 2013
Recall Status1 Terminated on September 12, 2013
Recall Number Z-0632-2013
Recall Event ID 63838
Premarket Notification
510(K) Number
K060318 
Product Classification Nadh Oxidation/Nad Reduction, Ast/Sgot - Product Code CIT
Product ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
Code Information Lot number: 00456-4108
Recalling Firm/
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine, California 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
DESIGN: 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 66886 units
Distribution Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CIT and Original Applicant = HORIBA ABX
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