FDA Device recall Z-0924-2014
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…
- FDA Device
- Class III
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class III recall of 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… by Horiba Instruments, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0924-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-12-18 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Horiba Instruments |
| Distribution | US |
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
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.
Identifiers
| code_info | Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expir…Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Horiba Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0924-2014%22
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