Phadia US Inc recalls
Every recall we track for Phadia US Inc — 6 in all, from 2017–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Phadia US Inc peaked in 2017 (3); 6 since 2017.
All FDA recall records for Phadia US Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 3 | 0 | 3 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 2 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Phadia US Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Phadia US Inc recalls
4 shown- Lower riskMedical device
Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin
Phadia US Inc recalls 2500EE instruments that may show higher results for gliadin tests than the 2500 instrument. Affected units have specific serial numbers and were sold for celiac disease testing.
PhadiaMay 1, 2023 - Lower riskMedical device
Phadia US Inc recalls EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA
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.
PhadiaDec 14, 2020 - Lower riskMedical device
Phadia US Inc recalls ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative
Phadia recalls ImmunoCAP Allergen c5 Ampicilloyl (article 14-4450-01) due to stability problems. This affects specific IgE test kits with lot numbers 990DS through 990DY.
PhadiaDec 18, 2017 - Lower riskMedical device
Phadia US Inc recalls Phadia 1000 Instrument, Article Number 12-3800-01.
Phadia recalls its 1000 Instrument (Article 12-3800-01) due to a Retry command malfunction that may cause wash solution shortages and inaccurate test results. Affected users should contact Phadia for guidance.
PhadiaJul 5, 2017
Phadia US Inc recall questions
How many recalls has Phadia US Inc had?
6 recalls from Phadia US Inc are on record with U.S. safety agencies, from 2017–2023.
What is the most recent Phadia US Inc recall?
Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin, dated May 1, 2023. Every Phadia US Inc recall is listed on this page, newest first.
What should I do if I have a recalled Phadia US Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Phadia US Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.