Reported Oct 16, 2019 · Terminated
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI #…
Horiba Instruments Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Horiba Instruments Incorporated · 34 Bunsen · Irvine, CA · 92618-4210
Is this the product you have?
- Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400
- REF
A11A01631Model/Part # 1220001631UDI # 03610230004944
- Lot codes and dates
- All Lots; All Software versions
- Amount recalled
- 1539 Chemistry Analyzers
Where it was sold
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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