Horiba ABX PENTRA Lactic Acid Reagent Recalled for Interference
Horiba Instruments Inc. is recalling ABX PENTRA Lactic Acid CP reagents because N-acetylcysteine in patient blood can cause falsely low results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (falsely low diagnostic results) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Horiba Instruments Inc. is recalling 216 units of ABX PENTRA Lactic Acid CP reagent (ref. A11A01721). The product is an in vitro diagnostic reagent intended for the quantitative determination of lactic acid in plasma by colorimetry. 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 lactic acid results, potentially affecting the diagnosis and treatment of lactic acidosis.
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. Users should stop using the affected reagents and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (ab
- 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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