Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 11/25/2020
Class II
PRODUCT
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
REASON
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.
RECALLING FIRM/MANUFACTURER
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
DISTRIBUTION
U.S. Nationwide and International