The Recall Desk
LowFDA (Devices)·Z-1048-2013·Announced 2013-04-10

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.

What this means for you

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.
Category
Medical Device — Laboratory Analyzer
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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · software error

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