—#130331

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.

FDA product code: DIP — Enzyme Immunoassay, Diphenylhydantoin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K911056
Affected lot / code info: lot FA5154, exp. 2015-06-03

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800) 441-9250, or your local Siemens technical support representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay

Timeline

Recall initiated: 2014-09-24
Posted by FDA: 2014-10-29
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130331. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.