Dimension¿ Integrated Chemistry Systems intended to measure a variety… — Class III medical device recall Z-2133-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-08-06, distributed in AR, FL, IA, IL, KS, LA, MT, OH…. There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instrume
| Recall number | Z-2133-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2014-05-27 |
| Classified | 2014-07-30 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2014-12-15 |
| Distributed | AR, FL, IA, IL, KS, LA, MT, OH, WI |
| Quantity | 15 |
Product
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Reason for recall
There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
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-2133-2014. 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.