CLASS III Device recall · Reported 29 Aug 2018 · FDA Enforcement Report

is a qualitative indirect enzyme immunoassay enzyme-linked recalled

Euro Diagnostica AB is recalling is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (Elisa), distributed in Minnesota. The recall was initiated on 21 Oct 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #'s: TS 1740 (kit) and TS 1743 (PC)

Quantity recalled4

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-2922-2018
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 qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Where it was distributed

Minnesota

Questions about this recall

Why was it recalled?

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Which lots are affected?

Lot #'s: TS 1740 (kit) and TS 1743 (PC)

Where was it sold?

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 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.

Other products in this recall event

3 other products · FDA event 80684

This product is part of a recall event; the main page for the event is is a quantitative/qualitative enzyme-linked immunosorbent recalled.

Reported	Class	Recall	Company	Reason	Where
29 Aug 2018	CLASS III	is a quantitative/qualitative enzyme-linked immunosorbent recalled	Euro Diagnostica AB	Labeling Errors	MN
29 Aug 2018	CLASS III	is a quantitative/qualitative enzyme-linked immunosorbent recalled	Euro Diagnostica AB	Labeling Errors	MN
29 Aug 2018	CLASS III	is a quantitative/qualitative enzyme-linked immunosorbent recalled	Euro Diagnostica AB	Labeling Errors	MN

More recalls from Euro Diagnostica AB

All 8

Reported	Class	Recall	Company	Reason	Where
29 Aug 2018Device	CLASS III	is a quantitative/qualitative enzyme-linked immunosorbent recalled	Euro Diagnostica AB	Labeling Errors	MN
29 Aug 2018Device	CLASS III	is a quantitative/qualitative enzyme-linked immunosorbent recalled	Euro Diagnostica AB	Labeling Errors	MN
29 Aug 2018Device	CLASS III	is a quantitative/qualitative enzyme-linked immunosorbent recalled	Euro Diagnostica AB	Labeling Errors	MN
29 Aug 2018Device	CLASS II	Immunoscan CCPlus test kit is an enzyme-linked recalled	Euro Diagnostica AB	Potency & Assay	MN, TX
14 Mar 2018Device	CLASS II	Diastat anti-Nuclear antibody (Ana) / Diastat Ana Elisa recalled	Euro Diagnostica AB	Potency & Assay	Nationwide

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