Home / Recalls / Horiba Instruments Incorporated / Z-0119-2020

Z-0119-2020 Class II Terminated

Recalled by Horiba Instruments Incorporated — Irvine, CA

Recall Details

Product Type: Devices
Report Date: October 16, 2019
Initiation Date: October 30, 2018
Termination Date: June 16, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1539 Chemistry Analyzers

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).

Distribution Pattern

US: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY

Code Information

All Lots; All Software versions