FDA Medical Device Recalls (openFDA)
Phadia Ab: 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.
- Recall number
- Z-1907-2019
- Recalling firm
- Phadia Ab
- 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.
- Status
- Terminated
- Initiated
- 2019-05-10
- Posted
- not on file
- Terminated
- 2020-06-02
- Reason
- Potential for reporting low assay results
- Root 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
- 30 kits
- Distribution
- US Nationwide n the states of NJ, NY, MI, WV, TX including PR
- Lot, serial or model codes
- UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085
- 510(k) numbers
- ["K102673","K182747"]
- PMA numbers
- not on file
- Product code
- DHR
- Firm FEI
- 3002807876
- Firm city
- Uppsala
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28