EliA RF IgM Well, REF 14-5600-01 recallZ-1907-2019 · Phadia Ab · initiated May 10, 2019

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Phadia Ab or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for reporting low assay results

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number: Z-1907-2019
Status: Terminated
Initiated by the company: May 10, 2019
Recalling firm: Phadia Ab
Quantity: 30 kits
Product code: DHR
FDA submissions: K102673, K182747
Distribution: US Nationwide n the states of NJ, NY, MI, WV, TX including PR

Product description

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 (models, lots, serial numbers)

UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

EliA RF IgM Well DECC056000
Phadia AB · SYSTEM, TEST, RHEUMATOID FACTOR
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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