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.
Enforcement
- Recall Number
- Z-0718-2023
- Event ID
- 91164
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 21, 2022
- Initiation Date
- November 4, 2022
- Classification Date
- December 15, 2022
- Address
- 333 Coney St, N/A, East Walpole, MA, 02032-1516, United States
Description
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.
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
UDI:-DI: (01)00630414278735(10)565(17)20221130 Kit Lot 565
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