FDAClass IIDecember 30, 2015

Reagent Management System recall

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿…

Why was Reagent Management System 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Dimension EXL with LM STM Catalog Numbers 778031.911 (Domestic) /778031.931 (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¿…
Recalling firm
Siemens Healthcare Diagnostics Inc.
Quantity
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.
Recall date
December 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls