CLASS III Device recall · Reported 6 Aug 2014 · FDA Enforcement Report
Dimension¿ Integrated Chemistry Systems intended recalled
Siemens Healthcare Diagnostics is recalling Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in, distributed in 8 states. The recall was initiated on 27 May 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2133-2014
- FDA event ID
- 68400
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 May 2014
- FDA classified
- 30 Jul 2014
- Reported
- 6 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 May 2014 | Recall initiated by company | |
| 30 Jul 2014 | Classified by FDA | +64 days |
| 6 Aug 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
Product as listed by the FDA
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Where it was distributed
FL LA AR IA OH OH WI IL LA KS MT
Questions about this recall
Why was it recalled?
There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
Which lots are affected?
DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX
Where was it sold?
FL LA AR IA OH OH WI IL LA KS MT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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