Siemens Healthcare Diagnostics Inc.: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.

Agency Publication Date: December 22, 2015

Affected Products

Product: Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.

Dimension EXL with LM Catalog Numbers 778021.911 (Domestic)/ 778021.931 (Intl). All serial numbers.

Product: Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.

Dimension EXL with LM STM Catalog Numbers 778031.911 (Domestic) /778031.931 (Intl). All serial numbers.

Product: Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.

Dimension RxL Max w/o HM Catalog Numbers 752000.901 (Domestic)/752000.921 (Intl). RxL Max HM Catalog Numbers 752000.911 (Domestic)/752000.931 (Intl). All serial numbers.

Product: Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.

Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.901 (Domestic)/753000.902 (Intl). All serial numbers.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72738

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics Inc.

Manufactured In: United States

Units Affected: 4 products (106; 4; 3; 151)

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Sources: FDA iRES · Raw API Response

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Affected Products

Dimension EXL with LM Catalog Numbers 778021.911 (Domestic)/ 778021.931 (Intl). All serial numbers.

Dimension EXL with LM STM Catalog Numbers 778031.911 (Domestic) /778031.931 (Intl). All serial numbers.

Dimension RxL Max w/o HM Catalog Numbers 752000.901 (Domestic)/752000.921 (Intl). RxL Max HM Catalog Numbers 752000.911 (Domestic)/752000.931 (Intl). All serial numbers.

Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.901 (Domestic)/753000.902 (Intl). All serial numbers.