Horiba Instruments Incorporated: Medical Device Recall in 2019 - (Recall #: Z-0119-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944

Product Classification:

Class II

Date Initiated: October 30, 2018

Date Posted: October 16, 2019

Recall Number: Z-0119-2020

Event ID: 83701

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).

Status: Terminated

Product Quantity: 1539 Chemistry Analyzers

Code Information:

All Lots; All Software versions

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

Voluntary or Mandated:

Voluntary: Firm initiated