ABX PENTRA Urine Control L/H recallZ-0924-2014 · Horiba Instruments, Inc dba Horiba Medical · initiated Dec 18, 2013
Class III Terminated All recalls posted in February 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Horiba Instruments, Inc dba Horiba Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Pending
What the company is doing
HORIBA Medical sent an Urgent Safety Notice dated December 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to update their Quality Control procedures to include the new Creatinine Target Ranges for the ABX PENTRA Urine Control L/H Reference #: A11A01674 and Lot #s: 1207001, 1303601, and 1300701. Customers were instructed to complete and return the enclosed response form to verify their understanding of the Field Safety Notice. Customers with questions were instructed to contact their local HORIBA Medical representative. For questions regarding this recall call 949-453-0500.
Recall details
- Recall number
- Z-0924-2014
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Dec 18, 2013
- Posted by the FDA
- Feb 3, 2014
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 531
- Product code
- JJY
- FDA submissions
- K110137, K110530
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
Product description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K110137, K110530 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ABX PENTRA CREATININE 120 CP 1220001933Horiba Abx Sas · Alkaline Picrate, Colorimetry, Creatinine1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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