Dimension Integrated Chemistry Systems intended to measure… recallZ-2133-2014 · Siemens Healthcare Diagnostics, Inc. · initiated May 27, 2014
Class III Terminated All recalls posted in July 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2133-2014
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- May 27, 2014
- Posted by the FDA
- Jul 30, 2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 15
- Product code
- JJE
- FDA submissions
- K073604, K112999, K130276
- Distribution
- FL LA AR IA OH OH WI IL LA KS MT
Product description
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Code information (models, lots, serial numbers)
DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX
Other devices under the same FDA submission
2 devices cleared under K073604, K112999, K130276 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension® EXL™ with LM Integrated Chemistry System 10472176Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall73 reports
- Dimension® QuikLYTE® Multisensor Na+/K+/Cl- 10445058Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION-SPECIFIC, CHLORIDE34 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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