CLASS III Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
is a quantitative/qualitative enzyme-linked immunosorbent recalled
Euro Diagnostica AB is recalling is a quantitative/qualitative enzyme-linked immunosorbent assay (Elisa) for the detection, distributed in Minnesota. The recall was initiated on 21 Oct 2016 and the FDA has classified it as Class III.
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-2921-2018
- FDA event ID
- 80684
- Recalling firm
- Euro Diagnostica AB, Malmo
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Oct 2016
- FDA classified
- 23 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Oct 2016 | Recall initiated by company | |
| 23 Aug 2018 | Classified by FDA | +671 days |
| 29 Aug 2018 | 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
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Product as listed by the FDA
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.
Where it was distributed
MN
Questions about this recall
Is is a quantitative/qualitative enzyme-linked immunosorbent assay (Elisa) for the detection recalled?
Yes. Euro Diagnostica AB recalled is a quantitative/qualitative enzyme-linked immunosorbent assay (Elisa) for the detection on 21 Oct 2016. The recall is Class III and its status is Terminated. Recall number Z-2921-2018.
Why was it recalled?
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Which lots are affected?
Lot #'s: TS 2819 (kit) and TS 2841 (PC)
Where was it sold?
MN
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Euro Diagnostica AB
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
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