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Recall Observatory FDA recall evidence

Device 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.

Z-1907-2019

May 10, 2019

Class II

Product summary

Firm
Phadia Ab
Event
Event 82979
Status
Terminated
Classification
Class II
Quantity
30 kits
Official record key
device-enforcement:Z-1907-2019

Official wording

Reason: Potential for reporting low assay results

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

Distribution pattern: US Nationwide n the states of NJ, NY, MI, WV, TX including PR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for reporting low assay results