Horiba ABX PENTRA Uric Acid CP Recalled for Interference
Horiba Instruments Inc is recalling ABX PENTRA Uric Acid CP assays 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. 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/testing errors without reported injuries.
Plain-English summary
Horiba Instruments Inc is recalling 216 units of the ABX PENTRA Uric Acid CP in vitro diagnostic assay (ref. A11A01670). The product is used for the quantitative determination of uric acid in human serum, plasma, and urine.
The recall is due to a potential for interference in the 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 assay. This interference can produce falsely low results.
The affected units were distributed in the United States to the following states: 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, and TN. There was no foreign distribution. All lots are affected.
The recalled product
- Product
- 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
- 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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