Lower riskMedical device recall · FDA · Published December 14, 2020
Phadia EliA dsDNA Well recall: False positive results risk
Phadia recalls specific EliA dsDNA Well kits for potential false positive results in lupus testing. Affected kits may give inaccurate results for systemic lupus diagnosis.
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).
Take action
Contact the company
📍Recalling firmPhadia US Inc4169 Commercial Ave · Portage, MI 49002-9701
“Phadia EliA dsDNA Well recall: False positive results risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63670-phadia-elia-dsdna-well-recall-false-positive-results-risk. Based on FDA recall #Z-1107-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1107-2021%22&limit=1).
Phadia US Inc recalled EliA dsDNA Well lots due to potential false positive results, according to the FDA on 2020-12-14. The Food and Drug Administration announced the Class II recall of 365 kits distributed nationwide.
How to tell if you have it
Brand: Phadia
Product: EliA dsDNA Well
Material Number: 14-5500-01
Carrier Lot Number: BFA3Y
Kit Lot Number: 0142
UDI: 07333066019406
The hazard
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results, which increases patient test results. The FDA reported no specific incidents or injuries in this record.
Context
GovInfoNow's records show Phadia US Inc has 3 other recalls on record since 2017-07-05. Other recent recalls of similar products include Immunotech Estrone RIA Kit Recall (2025-12-15), Tosoh ST AIA-Pack Testosterone Recall (2026-06-12), and BioFire Joint Infection Panel Recall (2026-04-22).
How to tell if you have this one
Check for the lot number 0142 on the kit label. The product was sold with the carrier lot number BFA3Y and material number 14-5500-01.
Brand
Phadia
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number 0142 on the kit label to identify affected units.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1107-2021 (December 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1107-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.