Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PENTRA C200 Recalled by Horiba Instruments, Inc dba Horiba Medical Due to Horiba Medical is recalling the ABX PENTRA AST...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Horiba Instruments, Inc dba Horiba Medical directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Horiba Instruments, Inc dba Horiba Medical
Horiba Instruments, Inc dba Horiba Medical has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report