Siemens Dimension EXL LM Analyzer Recalled for System Check Failures
Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL LM analyzers worldwide due to increased System Check failures that cause inconvenience but do not affect 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 recall is classified as FDA Class III, and the source text explicitly states that the errors have no impact on results, fitting the criteria for cosmetic or documentation issues that are unlikely to cause adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,207 units of the Siemens Dimension EXL LM analyzer (Material Number 10486890) distributed worldwide. The device is intended to measure a variety of analytes in human body fluids.
The recall was initiated after an investigation into customer complaints revealed an increase in System Check failures due to high System Check LOCI results. Siemens determined that these errors are caused by the current limit set for System Check LOCI results. The company states that these errors have no impact on the actual test results but may cause customer inconvenience.
This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences. Users of the affected devices should contact Siemens Healthcare Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). 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 10486890
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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