Recall Z-2140-2018 ยท DJR Enzyme Immunoassay, Methadone
Alere San Diego Inc. DBA Immunalysis Corporation
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/Tand
| Date | Nov 28, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On November 28, 2017, the firm sent their customer notifications of the recall stating the following: CUSTOMER REQUIRED ACTION 1. If you have product in your possession: " Immediately discontinue use and/or sale of affected product lot and place in quarantine. " Complete the enclose Customer Verification Form, within 10 days, indicating the quantity of product you have discarded or will return to lmmunalysis. " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com " Upon receipt of your Customer Verification Form, we will initiate shipment of |
| Quantity | 37 kits |
| Distribution | US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control S Immunalysis Corporation, Jul 24, 2015 |