Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. |
| Product | 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. |
| Quantity | 3956 |
| Distribution | Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahama… |
| Initiated | 2018-09-07 |
| Classified | 2018-11-14 |
| Terminated | 2020-11-16 |
| Recall number | Z-0466-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0466-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81237/
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