Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 12, 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 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 o
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 bee…
Horiba Instruments, Inc dba Horiba Medical recalled ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and… — a low-severity action.
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and… was recalled by Horiba Instruments, Inc dba Horiba Medical in February 12, 2014. Reason: HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX P…. Check the official notice for the remedy. Verify recall #Z-0924-2014 with the FDA Devices before acting.
The recall
Horiba Instruments, Inc dba Horiba Medical issued this low-severity FDA Devices recall — HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX P….
- Low
- severity level
- 531 units
- affected scope
- Class III
- classification
- February 12, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0924-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0924-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on December 18, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Horiba Instruments, Inc dba Horiba Medical is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 531.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
531
Related Recalls
6
6 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0924-2014 |
| Date reported | February 12, 2014 |
| Date initiated | December 18, 2013 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Firm location | Irvine, CA |
| Affected scope | 531 |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0924-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Horiba Instruments, Inc dba Horiba Medical. Units affected: 531.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2014. Severity: Low. Recall number: Z-0924-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0924-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported February 12, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.