CLASS II Device recall · Reported 10 Feb 2016 · FDA Enforcement Report
ABX Pentra Uric Acid CP recalled by Horiba Instruments
Horiba Instruments is recalling ABX Pentra Uric Acid CP, distributed in 29 states. The recall was initiated on 11 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0743-2016
- FDA event ID
- 73033
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2016
- FDA classified
- 2 Feb 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Jan 2016 | Recall initiated by company | |
| 2 Feb 2016 | Classified by FDA | +22 days |
| 10 Feb 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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).
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaFloridaGeorgiaIdahoIllinoisKansasKentuckyMarylandMichiganMinnesotaMississippiMontanaNorth CarolinaNebraskaNew MexicoNew YorkOhio
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All Lots
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 73033This product is part of a recall event; the main page for the event is ABX Pentra Glucose PAP CP recalled by Horiba Instruments.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ABX Pentra Glucose PAP CP recalled by Horiba Instruments | Horiba Instruments | Other | 29 states | |
| CLASS II | ABX Pentra Triglycerides CP recalled by Horiba Instruments | Horiba Instruments | Potency & Assay | 29 states | |
| CLASS II | ABX Pentra Lactic Acid CP recalled by Horiba Instruments | Horiba Instruments | Other | 29 states | |
| CLASS II | The ABX Pentra Cholesterol CP recalled by Horiba Instruments | Horiba Instruments | Potency & Assay | 29 states | |
| CLASS II | ABX Pentra Enzymatic Creatinine CP recalled by Horiba Instruments | Horiba Instruments | Other | 29 states |
More recalls from Horiba Instruments
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|---|---|---|---|---|---|
| Device | CLASS II | Horiba custom configured fluorescence instrument recalled | Horiba Instruments | Foreign Material | Nationwide |
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| Device | CLASS II | Reagent Cup, B1037307, Sap 1221037307 for use recalled | Horiba Instruments | Device Malfunction | Nationwide |
| Device | CLASS II | Reagent Cup, B1034626, Sap 1221034626 for use recalled | Horiba Instruments | Device Malfunction | Nationwide |
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