CLASS II ONGOING Device recall · Reported 31 Jan 2024 · FDA Enforcement Report

Liaison Hsv-2 Type Specific IgG recalled by Diasorin

Diasorin is recalling Liaison Hsv-2 Type Specific IgG, distributed nationwide in the US. The recall was initiated on 13 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775

Quantity recalled31992 units

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-0815-2024
FDA event ID: 93741
Recalling firm: Diasorin, Stillwater, MN
Classification: Class II
Status: Ongoing
Recall initiated: 13 Dec 2023
FDA classified: 25 Jan 2024
Reported: 31 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

13 Dec 2023	Recall initiated by company
25 Jan 2024	Classified by FDA	+43 days
31 Jan 2024	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

DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

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 Diasorin

All 6

Reported	Class	Recall	Company	Reason	Where
18 Dec 2024Device	CLASS II	Liaison Q.S.E.T. Device Plus recalled by Diasorin	Diasorin	Packaging Defects	MN
7 Apr 2021Device	CLASS II	Liaison 1-84 PTH Assay recalled by Diasorin	Diasorin	Potency & Assay	Nationwide
9 Sep 2020Device	CLASS II	Parvovirus B19 IgG EIA kit recalled by Diasorin	Diasorin	Other	11 states
30 Nov 2016Device	CLASS II	Liaison Estradiol II Gen recalled by Diasorin	Diasorin	Potency & Assay	Nationwide
29 Apr 2015Device	CLASS II	Pro-Trac II Tacrolimus Elisa kit recalled by Diasorin	Diasorin	Potency & Assay	CA

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