Class 2 Device Recall EliA dsDNA Immunoassay EliA ANA Control

• Date Initiated by Firm: December 14, 2020
• Date Posted: February 11, 2021
• Recall Status: Terminated on August 04, 2022
• Recall Number: Z-1107-2021
• Recall Event ID: 87161
• 510(K)Number: K072393
• Product Classification: Antinuclear Antibody immunological test system - Product Code LSW
• Product: EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
• Code Information: Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
• FEI Number: 3002807876
• Recalling Firm/ Manufacturer: Phadia US Inc; 4169 Commercial Ave; Portage MI 49002-9701
• For Additional Information Contact: Phadia recall public contact; 269-833-1819
• Manufacturer Reason for Recall: Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
• FDA Determined Cause: Under Investigation by firm
• Action: Phadia US Inc. (Initial Importer/Distributor) issued notification to consignees via phone and FedEx overnight delivery Dec. 17-18 . Letter states reason for recall, health risk and action to take: Customers are asked to perform the following steps: 1.Scrap EliA dsDNA Well lot BFA3Y/0142 and order a replacement free of charge 2. Assess test results from EliA dsDNA Well lot BFA3Y/0142 and determine if retesting of samples is warranted in accordance with internal operating procedures. 3. Complete the Acknowledgement Form in the Medical Device Field Safety Notice and return the response to the contact person described. Any questions concerning this issue, contact Phadia US Technical Support at 1-800-346-4364, option #2.
• Quantity in Commerce: 365 kits US
• Distribution: US Nationwide distribution.
• 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 = LSW