Reported Jul 10, 2019 · Terminated
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative…
Phadia Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Phadia Ab · Rapsgatan Plant · Uppsala, N/A · N/A
Is this the product you have?
- EliA RF IgM Well
- REF 14-5600-01 Product UsageUsage: 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
- Lot codes and dates
- UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085
- Amount recalled
- 30 kits
Where it was sold
Why it was recalled
Potential for reporting low assay results
This product could cause temporary or reversible health problems — stop using it.
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