Dimension¿ Integrated Chemistry Systems intended to recall
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Why was Dimension¿ Integrated Chemistry Systems intended to 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX
- Product
- Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 15
- Distribution
- FL LA AR IA OH OH WI IL LA KS MT
- Recall date
- August 6, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)