Horiba Instruments Recalls ABX PENTRA Triglycerides Assay Due to Interference
Horiba Instruments Inc is recalling ABX PENTRA Triglycerides CP assays because N-acetylcysteine in patient blood can cause falsely low results.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard involves potential diagnostic errors (falsely low results) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Horiba Instruments Inc is recalling 216 units of the ABX PENTRA Triglycerides CP in vitro diagnostic assay (ref. A11A01640). The product is used for the quantitative determination of triglycerides in human serum and plasma.
The recall was issued 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 assay. This interference can produce falsely low results. The recall includes all lots of the product.
The affected units were distributed in the United States to facilities in California, New York, Alabama, Oklahoma, Minnesota, Mississippi, Maryland, Texas, Kentucky, West Virginia, Montana, Illinois, Florida, Virginia, Washington, Michigan, Kansas, Nebraska, Pennsylvania, Ohio, Idaho, Oregon, Arkansas, Arizona, New Mexico, North Carolina, South Carolina, Georgia, and Tennessee. No foreign distribution occurred. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- 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…
- 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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