Z-0119-2020 Class II Terminated
FDA device recall Z-0119-2020 was initiated by Horiba Instruments Incorporated on October 30, 2018 and is designated Class II. 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 pat… The recall status is terminated (terminated June 16, 2020). Affected quantity: 1539 Chemistry Analyzers.
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