Z-0718-2023Class II

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN)...

Name: Z-0718-2023 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN)...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-11-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-11-04 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of... on 2022-11-04. FDA classified it as Class II and gives the reason as "Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0718-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-04
Posted: 2022-12-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
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
FDA root cause: Under Investigation by firm
Action: Siemens initiated issued on 11/04/2022 an Urgent Medical Device Correction (UMDC) IMC 23-01.A.US to US customers, an Urgent Field Safety Notice (UFSN) IMC 23-01.A-1.OUS to Outside the US (OUS, except Japan) customers, and an Urgent Field Safety Notice (UFSN) IMC 23-01.A-2.OUS (Japan) to customers in Japan . Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Discontinue use of the kit lots listed in Table 1. Review your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative
Quantity in commerce: 560 kits
Distribution: 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¿¿¿¿¿
Product codes and lots: UDI:-DI: (01)00630414278735(10)565(17)20221130 Kit Lot 565

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0718-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0717-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0718-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15

Product code DHB

K101572Class IIImmulite 2000 3Gallergy Specific Ige Assay KitSiemens Healthcare Diagnostics / cleared 2011-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)