PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 30, 2015 Initiated: November 10, 2015 #Z-0459-2016

Product Description

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.

Reason for Recall

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.

Details

Units Affected
4
Distribution
US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
Location
Brookfield, CT

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics Inc.. Units affected: 4.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0459-2016.

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