Reported Nov 5, 2014 · Terminated
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
- Lot codes and dates
lot FA5154exp. 2015-06-03
- Amount recalled
- 1733
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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