Siemens Healthcare Diagnostics, Inc. Recall: siemens Dimension¿ Phenytoin Flex¿ Reagent Ca
Siemens Healthcare Diagnostics, Inc. Recall: siemens Dimension¿ Phenytoin Flex¿ Reagent Ca is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Healthcare Diagnostics, Inc.; Product: siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| Product | 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. |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay |
| Recall initiated | 20140924 |
| Recall number | Z-0148-2015 |
| Category | device |
| State | DE |
| Country | United States |
$29/mo
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