Recall

Class II — Horiba Instruments, Inc dba Horiba Medical

Recalling firm	HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
Registered facility	View this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
Classification	Class II
Status	Terminated
Reason	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.
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.
Quantity	384 units
Distribution	Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Initiated	2012-10-10
Classified	2013-01-03
Terminated	2013-09-12
Recall number	Z-0633-2013
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Horiba Instruments, Inc dba Horiba Medical (Z-0633-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63838/

Not open yet

Alerts for HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.