Class 3 Device Recall lmmunalysis EDDP Urine Control Set 1

• Date Initiated by Firm: November 28, 2017
• Create Date: June 08, 2018
• Recall Status: Terminated on January 29, 2021
• Recall Number: Z-2140-2018
• Recall Event ID: 80096
• 510(K)Number: K151395
• Product Classification: Enzyme immunoassay, methadone - Product Code DJR
• 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.
• Code Information: Part Number: 3006-5, Lot Number: EK16135
• Recalling Firm/ Manufacturer: Alere San Diego Inc. DBA Immunalysis Corporation; 829 Towne Center Dr; Pomona CA 91767-5901
• For Additional Information Contact: Rochelle Timbang; 207-730-5738
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 replacement product in the quantity indicated on the form and, if applicable, will contact you to arrange product return. " Return product as directed. 2. If you have no remaining product in your possession: " Complete the enclosed Customer Verification Form, within 10 days, indicating "We do not have any affected product - it has been consumed". " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com 3. Share this information with your staff and retain this notification as part of your records. Please complete this form and return within 10 days even if you do not have any remaining product. Send form to lmmunalysis at Fax 909-482-0850 or by e-mail to rtimbang@immunalysis.com For further questions, please call (207) 730-5738.
• Quantity in Commerce: 37 kits
• Distribution: US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DJR and Original Applicant = Immunalysis Corporation