Horiba ABX Pentra Lipase CP Analyzer Recall for Interference
Horiba Instruments is recalling ABX Pentra Lipase CP analyzers because triglyceride and cholesterol interference may cause false abnormal lipase results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential diagnostic errors.
Plain-English summary
Horiba Instruments Incorporated is recalling 1,539 ABX Pentra Lipase CP chemistry analyzers (REF: A11A01631, Model/Part # 1220001631). The recall covers all lots and all software versions of the device, which is used in the ABX Pentra 400/Pentrac400 systems.
The recall is due to a potential for the analyzer to report abnormal results caused by interference from triglyceride and cholesterol components. This interference may lead to an overestimation of lipase concentration, causing the instrument to declare a patient result as abnormal when it is actually normal (below 38 U/L or the laboratory's reference value).
The affected devices were distributed to laboratories in 38 U.S. states, including Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming. Users should contact Horiba Instruments Incorporated for instructions on how to proceed.
The recalled product
- Product
- Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
- Manufacturer
- Horiba Instruments Incorporated
- Affected units
- 1,539
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots
- All Software versions
Distribution
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