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

Recall Z-0465-2019 — Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.

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-0465-2019
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)
10460277
Reported risk: There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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