Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
FDA device recall Z-2133-2014 · posted 2014-07-30 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 15
- Distribution
- FL LA AR IA OH OH WI IL LA KS MT
- Date initiated
- 2014-05-27
- Date posted
- 2014-07-30
- Date terminated
- 2014-12-15
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION EXL WITH LM SYSTEM (K130276) | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM (K112999) | Siemens Healthcare Diagnostics | 2011-11-22 |
| DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD (K073604) | Dade Behring, Inc. | 2008-03-13 |