Food, drugs, devices › Horiba Instruments Inc
Device recall: The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholester
FDA enforcement event 73033 is a device recall by Horiba Instruments Inc of Irvine, CA, initiated 11 Jan 2016 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 7 Jun 2016. Initiation: voluntary: firm initiated. Horiba Instruments Inc has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Horiba Instruments Inc, Irvine, CA.
Reason for recall
"N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method."
Distribution
"U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0738-2016 | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. | 216 | Class II | Terminated | 10 Feb 2016 |
| Z-0739-2016 | ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction. | 216 | Class II | Terminated | 10 Feb 2016 |
| Z-0740-2016 | ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry. | 216 | Class II | Terminated | 10 Feb 2016 |
| Z-0741-2016 | ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). | 216 | Class II | Terminated | 10 Feb 2016 |
| Z-0742-2016 | ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. | 216 | Class II | Terminated | 10 Feb 2016 |
| Z-0743-2016 | ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). | 216 | Class II | Terminated | 10 Feb 2016 |
Context
Other enforcement events for Horiba Instruments Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Feb 2016 | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyze | Device | Class II | 2 |
| 19 Nov 2014 | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Li | Device | Class II | 1 |
All 3 events for Horiba Instruments Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Jun 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.