Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

Is my product affected?

Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

• UPC 00630414002026

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

What happened

Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer units with software versions V1.19.0 and V1.19.2 due to issues with scanning new reagent lot test definitions. The recall affects 166 total units distributed nationwide and internationally, including 15 units in the United States and 151 units overseas across countries including Canada, the United Kingdom, France, Germany, Japan, Brazil, and others.

The source document does not specify a remedy for affected consumers.

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

Hazard

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Details from the source

Reason for recall: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 Distribution: Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam Quantity: 166 total US: 15; OUS:151 Lot/code info: (SW) version V1.19.0 and V1.19.2 UDI: 00630414002026

Source

Official record: FDA (Device enforcement) ↗

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

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