Siemens Dimension EXL 200 Recalled for System Check Failures
Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL 200 analyzers worldwide due to increased System Check failures that cause inconvenience but do not impact test results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, and the source text explicitly states that the errors have no impact on results, only causing customer inconvenience, which aligns with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,207 units of the Siemens Dimension EXL 200 (Siemens Material Number 10636929) worldwide. The device is intended to measure a variety of analytes in human body fluids.
The recall was initiated after an investigation of customer complaints confirmed an increase in System Check failures due to high System Check LOCI results. Siemens determined that many of these errors are due to the current limit set for System Check LOCI results.
The source text states that these errors have no impact on results but may cause customer inconvenience. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 2,207
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Siemens Material Number 10636929
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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