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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
PENTRA C200		see related information
Date Posted January 03, 2013
Recall Number Z-0633-2013
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, California 92618-4210
For Additional Information Contact Kim Walker
714-273-9254
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.
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.
 
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