Horiba ABX PENTRA Cholesterol CP Reagent Recalled for Interference
Horiba Instruments Inc is recalling 216 units of ABX PENTRA Cholesterol CP reagent because N-acetylcysteine 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. The hazard involves potential diagnostic errors (falsely low results) due to chemical interference, which fits the criteria for moderate severity involving low-risk contamination or labeling/functional issues without reported serious injury.
Plain-English summary
Horiba Instruments Inc is recalling 216 units of the ABX PENTRA Cholesterol CP reagent (ref. A11A01634). This in vitro diagnostic assay is used for the quantitative determination of cholesterol in human serum and plasma. The recall covers all lots of the product.
The recall was initiated because 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 cholesterol results. The product was distributed in the United States to specific states including California, New York, and Texas, with no foreign distribution.
Healthcare facilities and laboratories that purchased this product should stop using the reagent and contact Horiba Instruments Inc for further instructions. Patients who have had cholesterol tests performed using this reagent while being treated for paracetamol overdose should consult their healthcare provider to discuss the potential for inaccurate results.
The recalled product
- Product
- 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 c
- 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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