CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
EliA dsDNA Well recalled by Phadia US
Phadia US is recalling EliA dsDNA Well, distributed nationwide in the US. The recall was initiated on 14 Dec 2020 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-1107-2021
- FDA event ID
- 87161
- Recalling firm
- Phadia US, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2020
- FDA classified
- 11 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Dec 2020 | Recall initiated by company | |
| 11 Feb 2021 | Classified by FDA | +59 days |
| 17 Feb 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
Product as listed by the FDA
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is EliA dsDNA Well recalled?
Yes. Phadia US recalled EliA dsDNA Well on 14 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-1107-2021.
Why was it recalled?
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
Which lots are affected?
Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
Where was it sold?
US Nationwide distribution.
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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