Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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