CLASS II Device recall · Reported 10 Jul 2019 · FDA Enforcement Report
EliA RF IgM Well recalled by Phadia Ab
Phadia Ab is recalling EliA RF IgM Well, distributed nationwide in the US. The recall was initiated on 10 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1907-2019
- FDA event ID
- 82979
- Recalling firm
- Phadia Ab, Uppsala, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2019
- FDA classified
- 1 Jul 2019
- Reported
- 10 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 10 May 2019 | Recall initiated by company | |
| 1 Jul 2019 | Classified by FDA | +52 days |
| 10 Jul 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for reporting low assay results
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide n the states of NJ, NY, MI, WV, TX including PR
Nationwide MichiganNew JerseyNew YorkPuerto RicoTexasWest Virginia
Questions about this recall
Is EliA RF IgM Well recalled?
Yes. Phadia Ab recalled EliA RF IgM Well on 10 May 2019. The recall is Class II and its status is Terminated. Recall number Z-1907-2019.
Why was it recalled?
Potential for reporting low assay results
Which lots are affected?
UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085
Where was it sold?
US Nationwide n the states of NJ, NY, MI, WV, TX including PR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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