Device product
lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.
Z-2140-2018
Product summary
- Event
- Event 80096
- Status
- Terminated
- Classification
- Class III
- Quantity
- 37 kits
- Official record key
device-enforcement:Z-2140-2018
Official wording
Reason: The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized.
Code information: Part Number: 3006-5, Lot Number: EK16135
Distribution pattern: US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
Derived failure modes
-
Potency or specification failure
does not meet specification