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U.S. Department of Health and Human Services

Class 2 Device Recall EliA RF IgM Immunoassay

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  Class 2 Device Recall EliA RF IgM Immunoassay see related information
Date Initiated by Firm May 10, 2019
Create Date July 01, 2019
Recall Status1 Terminated 3 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
Recalling Firm/
Manufacturer		 Phadia Ab
Rapsgatan Plant
Rapsgatan 7
Uppsala Sweden
Manufacturer Reason
for Recall		 Potential for reporting low assay results
FDA Determined
Cause 2		 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 and Original Applicant = Phadia AB
510(K)s with Product Code = DHR and Original Applicant = PHADIA US INC.
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