CLASS II Device recall · Reported 10 Jan 2018 · FDA Enforcement Report
Euro Diagnostica Diastat Ana recalled
Euro Diagnostica AB is recalling Euro Diagnostica Diastat Ana (anti-nuclear antibody) Elisa Diastat Ana (anti-nuclear, distributed in Minnesota, Nebraska, Texas. The recall was initiated on 14 Feb 2017 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-0306-2018
- FDA event ID
- 77107
- Recalling firm
- Euro Diagnostica AB, Malmo, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Feb 2017
- FDA classified
- 29 Dec 2017
- Reported
- 10 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Processing Deviation
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Feb 2017 | Recall initiated by company | |
| 29 Dec 2017 | Classified by FDA | +318 days |
| 10 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Where it was distributed
MN, NE, TX
Questions about this recall
Why was it recalled?
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
Which lots are affected?
Lot: TS 2076
Where was it sold?
MN, NE, TX
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Euro Diagnostica AB
All 8| 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 |
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