Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Clinical Chemistry Recalled by Horiba Instruments Incorporated Due to Potential for chemical analyzer to report abnormal results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Horiba Instruments Incorporated directly.
Affected Products
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Quantity: 1539 Chemistry Analyzers
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed to 40 states: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, WY
About Horiba Instruments Incorporated
Horiba Instruments Incorporated has 2 total recalls tracked by RecallDetector.
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report