ABX PENTRA Urine Control L/H — Class III medical device recall Z-0924-2014
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2014-02-12, distributed nationwide. HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PEN
| Recall number | Z-0924-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical, Irvine, CA, United States |
| Recall initiated | 2013-12-18 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-10-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 531 |
| Reason classes | potency |
| Lot numbers | 1207001, 1300701, 1303601 |
| Serial numbers | 1207001, 1300701, 1303601 |
| Model numbers | 1207001, 1300701, 1303601, A11A01674 |
Product
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.