Recall Z-0741-2016— Horiba Instruments Inc
Class II · Terminated
Class II FDA medical device recall by Horiba Instruments Inc, initiated 2016-01-11, terminated 2016-06-07. FDA's recall record names no specific 510(k) clearance for this event. 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 (abnormally high acidity of the blood).. Reason: N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method..
- Recalling firm
- Horiba Instruments Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-11
- Terminated
- 2016-06-07
- Firm location
- Irvine, CA, United States
Product description
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 (abnormally high acidity of the blood).
Reason for recall
N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.
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