Recall Z-0717-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0717-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-04

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-11-04. It names one FDA 510(k) clearance: K101572. Product: 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.. Reason: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-04
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K101572 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KITSiemens Healthcare Diagnostics·cleared 2011-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.