Reported Dec 30, 2015 · Terminated
Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module…
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc. · 101 Silvermine Rd · Brookfield, CT · 06804-2047
Is this the product you have?
- Reagent Management System (RMS)
- Dimension RxL Max w/o HM Product UsageThe 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
- Lot codes and dates
- 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.
- Amount recalled
- 3
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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