siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge recall
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test…
Why was siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge 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.
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?
lot FA5154, exp. 2015-06-03
- Product
- siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1733
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay
- Recall date
- November 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)