Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic… — Class II medical device recall Z-2553-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-09-03, distributed nationwide. The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, pote
| Recall number | Z-2553-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2014-07-16 |
| Classified | 2014-08-26 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2014-12-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 2,757 |
Product
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
Reason for recall
The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
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-2553-2014. 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.