Z-0633-2013Class II

PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using...

Name: Z-0633-2013 PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2012-10-10
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2012-10-10 / Terminated / root cause: software

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry... on 2012-10-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0633-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Posted: 2013-01-03
Terminated: 2013-09-12
Recalling firm: Horiba Instruments Incorporated
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root 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.
Product codes and lots: Lot number: 00456-4108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0633-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0632-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03
Z-0633-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03

Product code JJE

K103788Class IIPentra C200, Ise Module and Abx Pentra Glucose Hk Cp ReagentHoriba Abx Sas / cleared 2011-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)