Reported Aug 6, 2014 · Terminated
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Siemens Healthcare Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
- Lot codes and dates
DE271317DE271320DE271323DE271324DE271326DE271327DE271328DE271332 DE271341DE271343DE2713251225258920040828982004082899224719-AX
- Amount recalled
- 15
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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