Class 2 Device Recall EliA RF IgM Immunoassay

• Date Initiated by Firm: May 10, 2019
• Create Date: July 01, 2019
• Recall Status: Terminated on June 02, 2020
• Recall Number: Z-1907-2019
• Recall Event ID: 82979
• 510(K)Number: K102673 K182747
• Product Classification: System, test, rheumatoid factor - Product Code DHR
• Product: EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.
• Code Information: UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085
• FEI Number: 3002807876
• Recalling Firm/ Manufacturer: Phadia Ab; Rapsgatan Plant; Rapsgatan 7; Uppsala Sweden
• Manufacturer Reason for Recall: Potential for reporting low assay results
• FDA Determined Cause: Nonconforming Material/Component
• Action: On May 10, 2019, Corporate Thermo Fisher Scientific issued URGENT FIELD SAFETY NOTICES to customers by FedEx. Actions To Be Taken: Please review patient results obtained from lot 0085 and make note of the following: 1. If you have any of the above referenced material on hand, please discontinue use immediately and discard per your internal procedures. Notify all affected users in your facility to do the same. 2. All samples reported as positive (> 5 IU/ml) are positive, however the true concentration could be higher than reported. 3. The true concentration of a reported sample equal to 3.5  5 IU/ml could potentially be a positive sample. 4. Negative results between 2 IU/ml and 3.5 IU/ml are potentially false negative results. 5. Negative results < 2 IU/ml could be higher, but would still be reported as a negative result with a 60% higher concentration. 6. Complete and return the Customer Response Form. If you have any questions concerning this issue, please contact Phadia US, Inc. Technical Support at 1-800-346-4364, option #2.
• Quantity in Commerce: 30 kits
• Distribution: US Nationwide n the states of NJ, NY, MI, WV, TX including PR
• 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 = DHR; 510(K)s with Product Code = DHR