The Recall Desk
LowFDA (Devices)·Z-2133-2014·Announced 2014-08-06

Siemens Dimension Integrated Chemistry Systems Recalled for Photometer Misassembly

Siemens is recalling 15 Dimension Integrated Chemistry Systems due to a photometer misassembly issue that may shorten the life of the source lamp.

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 recall is classified as FDA Class III, and the source text states the devices are performing within specifications with no reported injuries or illnesses, fitting the criteria for cosmetic or documentation issues.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 15 Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. The recall is due to a misassembly issue with the photometer installed on these instruments.

Through internal investigation, Siemens confirmed that a limited number of Dimension photometers were misassembled. These photometers are currently performing within specifications, but the defect may lead to a shortened life of the source lamp.

The affected units were distributed to facilities in Florida, Louisiana, Arkansas, Iowa, Ohio, Wisconsin, Illinois, Kansas, and Montana. Specific lot codes associated with the recall include DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332, DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, and 224719-AX.

The recalled product

Product
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Affected units
15

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 (14)

  • DE271317
  • DE271320
  • DE271323
  • DE271324
  • DE271326
  • DE271327
  • DE271328
  • DE271332 DE271341
  • DE271343
  • DE271325
  • 12252589
  • 2004082898
  • 2004082899
  • 224719-AX

Distribution

Distributed in 9 states:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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