Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 11/25/2020
Atellica IM 1300 Analyzer – Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Recall Number: Z-0473-2021
Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values.
Siemens Healthcare Diagnostics, Inc. on 10/26/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US 392 units; OUS 449 units
U.S. Nationwide and International