Siemens Phenytoin Reagent Cartridge Recalled for Potential Test Bias
Siemens Healthcare Diagnostics is recalling 1,733 Phenytoin Flex Reagent Cartridges due to internal testing that confirmed a low absorbance range, which may result in biased or imprecise test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk diagnostic product where the defect creates a risk of harm through inaccurate results, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,733 units of the Dimension Phenytoin Flex Reagent Cartridge. The affected product is identified by lot FA5154 with an expiration date of June 3, 2015. The product was distributed nationwide in the United States, including Puerto Rico, as well as in Australia, Brazil, the Bahamas, Canada, Chile, India, Japan, and Uruguay.
The recall was initiated after internal testing confirmed a low absorbance range between the levels 1 and 5 calibrators for this specific lot. This technical issue results in the potential for a positive or negative bias and imprecision across the phenytoin assay range. The PTN method is an in vitro diagnostic test intended to measure phenytoin levels in human serum and plasma, which are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels to ensure appropriate therapy.
Healthcare facilities and laboratories should stop using the affected lot and contact Siemens Healthcare Diagnostics for further instructions. Consumers should not use the product for testing.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,733
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- lot FA5154
- exp. 2015-06-03
Distribution
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