Reagent Management System — Class II medical device recall Z-0458-2016
Terminated recall by Siemens Healthcare Diagnostics Inc., reported 2015-12-30, distributed nationwide. Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termi
| Recall number | Z-0458-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc., Brookfield, CT, United States |
| Recall initiated | 2015-11-10 |
| Classified | 2015-12-21 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 106 |
| Model numbers | 778021.911 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0458-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.