Euro Diagnostica AB recalls
Euro Diagnostica AB has 8 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 29 Aug 2018. The most frequent reason is labeling errors.
Total recalls8since 2017
Last 12 months0reported
Class I00% of total
Ongoing0latest 29 Aug 2018
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 38%Class III 5 63%
Why euro diagnostica ab is recalled
Product types
By year
All euro diagnostica ab recalls, newest first
8 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | is a quantitative/qualitative enzyme-linked immunosorbent recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS III | is a qualitative indirect enzyme immunoassay enzyme-linked recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS III | is a quantitative/qualitative enzyme-linked immunosorbent recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS III | is a quantitative/qualitative enzyme-linked immunosorbent recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS II | Immunoscan CCPlus test kit is an enzyme-linked recalled | Euro Diagnostica AB | Potency & Assay | MN, TX |
| Device | CLASS II | Diastat anti-Nuclear antibody (Ana) / Diastat Ana Elisa recalled | Euro Diagnostica AB | Potency & Assay | Nationwide |
| Device | CLASS II | Euro Diagnostica Diastat Ana recalled | Euro Diagnostica AB | Processing Deviation | MN, NE, TX |
| Device | CLASS III | Diastat(R) Ana (anti-Nuclear antibody) Euro Diagnostica recalled | Euro Diagnostica AB | Potency & Assay | 4 states |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.