Product Wiki · Recalls · U.S. FDA — Device Enforcement

Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System. — recall Z-0466-2019

U.S. FDA — Device Enforcement · United States · 2018-09-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0466-2019
Date of alert
2018-09-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10461745
Reported risk: There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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