Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0473-2021

Z-0473-2021 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

Recall Details

Product Type
Devices
Report Date
November 25, 2020
Initiation Date
October 26, 2020
Termination Date
April 19, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
US 392 units; OUS 449 units

Product Description

Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.

Code Information

Software version: V1.23.1 or lower UDI: 00630414007960

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