Recall Z-0148-2015 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
Siemens Healthcare Diagnostics, Inc.
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 the
| Date | Oct 29, 2014 (initiated Sep 24, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent an Urgent Medical Device Recall Notification dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed as follows: " Discontinue use and discard any remaining inventory of PTN lot FA5154, and complete the attached form indicating your replacement product needs in the attached Field Correction Effectiveness Form. " Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may have cause. If you |
| Quantity | 1733 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911056 | DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD E.I. Dupont DE Nemours & Co., Inc., Apr 3, 1991 |