Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control Recalled by Horiba Instruments, Inc dba Horiba Medical Due to HORIBA Medical is informing all ABX PENTRA Urine...
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
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Quantity: 531
Why Was This Recalled?
HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.
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