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.
This recall has been terminated (originally issued December 22, 2015).
- Recall Initiated
- November 10, 2015
- Posted
- December 22, 2015
- Terminated
- August 23, 2017
- Recall Number
- Z-0461-2016
- Quantity
- 151
- Firm Location
- Brookfield, CT
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
Siemens sent an Urgent Medical Device Correction (UMDC # DI-16-01.A.US) and Urgent Field Safety Notice (UFSN # DI-16-01.A.OUS) letters dated November 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. For questions contact your local Siemens technical support representative.