Siemens Dimension EXL Integrated Chemistry System in vitro… recallZ-2553-2014 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 16, 2014
Class II Terminated All recalls posted in August 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
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.
FDA root cause category: Device Design
What the company is doing
Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down.
Recall details
- Recall number
- Z-2553-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 16, 2014
- Posted by the FDA
- Aug 26, 2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2757
- Product code
- JJE
- FDA submissions
- K130276
- Distribution
- Nationwide and internationally, including Canada and Mexico
Product description
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.
Code information (models, lots, serial numbers)
All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338
Other devices under the same FDA submission
1 device cleared under 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
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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