CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report

Immulite 2000 Systems 3gAllergy Specific IgE Universal Kit recalled

Siemens Healthcare Diagnostics is recalling Immulite 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan, distributed nationwide in the US. The recall was initiated on 4 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI:-DI: (01)00630414962269(10)826(17)20221130; (01)00630414962269(10)830(17)20221130; (01)00630414962269(10)831(17)20221130; (01)00630414962269(10)832(17)20221130; (01)00630414962269(10)833(17)20221130. Kit Lots: 826, 830, 831,832, 833

Quantity recalled5,193 kits

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-0717-2023
FDA event ID: 91164
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Nov 2022
FDA classified: 15 Dec 2022
Reported: 21 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Mold
Device type: Other Medical Devices

Timeline

4 Nov 2022	Recall initiated by company
15 Dec 2022	Classified by FDA	+41 days
21 Dec 2022	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

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Product as listed by the FDA

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

Where it was distributed

Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Azerbaijan¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Ecuador¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Guatemala¿¿¿¿¿¿ Hong¿Kong¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Indonesia¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿ Japan¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Macedonia¿¿¿¿¿¿ Mexico¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Panama¿¿¿¿¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Philippines¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ South¿Africa¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uruguay, and Uzbekistan¿¿¿¿¿

Nationwide

Questions about this recall

Why was it recalled?

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Which lots are affected?

UDI:-DI: (01)00630414962269(10)826(17)20221130; (01)00630414962269(10)830(17)20221130; (01)00630414962269(10)831(17)20221130; (01)00630414962269(10)832(17)20221130; (01)00630414962269(10)833(17)20221130. Kit Lots: 826, 830, 831,832, 833

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 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.

Other products in this recall event

2 other products · FDA event 91164

This product is part of a recall event; the main page for the event is Immulite 2000 Systems 3gAllergy Specific IgE Universal Kit recalled.

Reported	Class	Recall	Company	Reason	Where
21 Dec 2022	CLASS II	Immulite 2000 Systems 3gAllergy Specific IgE Universal Kit recalled	Siemens Healthcare Diagnostics	Mold	Nationwide
21 Dec 2022	CLASS II	Immulite 2000 Systems 3gAllergy Specific IgE Universal Kit recalled	Siemens Healthcare Diagnostics	Mold	Nationwide

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