Siemens Healthcare Diagnostics Inc., IMC 23-01, IMMULITE

The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide instructions on actions that your laboratory must take. Siemens Healthcare Diagnostics Inc. has confirmed the potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples when tested using the
product listed in Table 1. Users may observe elevated IMMULITE 2000/IMMULITE 2000 XPi 3gAllergy Specific IgE Negative Quality Control (SMN: 10485107) results outside of the published range (0 - 0.10 kU/L) when tested with the supported panels that contain a mold specific allergen [Mixed Allergen Mold Panel 1 (MP1) and/or Mixed Allergen Inhalant Panel 6 (IP6)] and the kit lots listed in Table 1. The 3gAllergy Specific IgE Universal Kit Controls are not affected by this issue. In addition, the potential exists that patient sample results generated with any mold specific allergen and/or mixed allergen panel that contain a mold allergen may show falsely increased IgE reactivity. Siemens’ internal investigation showed concentrations up to 0.214 kU/L in patient samples expected to result <0.10 kU/L. All other non-mold allergens and mixed allergen panels that do not contain mold allergen(s) are not affected. This issue is isolated to the kit lots listed in Table 1.
Siemens is currently investigating root cause.