Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material

Is my product affected?

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

• UPC 00630414007960

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling the Atellica IM 1300 Analyzer, an automated immunoassay analyzer used to perform diagnostic tests on clinical specimens. The recall affects 392 units in the United States and 449 units internationally across numerous countries worldwide. The problem occurs when the analyzer scans a barcode for a new reagent kit lot with a newer Test Definition (TDef) version than the current system version—this can cause some customer-defined settings for that assay to reset to their default values, potentially resulting in falsely low or high test results.

The affected devices have software version V1.23.1 or lower. The recall notice does not specify a remedy or recommended action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 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, Quantity: US 392 units; OUS 449 units Lot/code info: Software version: V1.23.1 or lower UDI: 00630414007960

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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