Horiba Instruments Recalls ABX PENTRA Enzymatic Creatinine Reagent Due to Interference
Horiba Instruments Inc. is recalling ABX PENTRA Enzymatic Creatinine CP reagent because N-acetylcysteine in patient blood can cause falsely low results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a diagnostic error (falsely low results) rather than a direct physical injury or contamination, fitting the Moderate severity criteria for low-risk issues or labeling/methodology errors.
Plain-English summary
Horiba Instruments Inc. is recalling 216 units of ABX PENTRA Enzymatic Creatinine CP reagent (ref. A11A01907). This in vitro diagnostic reagent is intended for the quantitative determination of creatinine in human serum, plasma, and urine using an enzymatic method.
The recall is due to a potential for inaccurate test results. N-acetylcysteine (NAC), which is present in the blood of patients treated for paracetamol overdose, can interfere with the Trinder reaction used by the reagent. This interference can produce falsely low creatinine results.
The affected product was distributed in the United States to facilities in 28 states, including California, New York, and Texas. No foreign distribution occurred. Users of this reagent should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Horiba Instruments Inc
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 6 recalled by Horiba Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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