Recall Z-0119-2020— Horiba Instruments Incorporated
Class II · Terminated
Class II FDA medical device recall by Horiba Instruments Incorporated, initiated 2018-10-30, terminated 2020-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944. Reason: Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory)..
- Recalling firm
- Horiba Instruments Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-30
- Terminated
- 2020-06-16
- Firm location
- Irvine, CA, United States
Product description
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Reason for recall
Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).
Data sourced from openFDA. This site is unofficial and independent of the FDA.