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Recall Observatory FDA recall evidence

Device product

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

Z-0119-2020

October 30, 2018

Class II

Product summary

Firm
Horiba Instruments Incorporated
Event
Event 83701
Status
Terminated
Classification
Class II
Quantity
1539 Chemistry Analyzers
Official record key
device-enforcement:Z-0119-2020

Official wording

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).

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).