Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0716-2023 — 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

U.S. FDA — Device Enforcement · United States · 2022-11-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0716-2023
Date of alert: 2022-11-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00630414982939

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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