Siemens allergy test kits recalled for false mold allergen reactivity results
Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for false diagnostic results and no reported illnesses. The product poses risk of harm through false allergy test results leading to incorrect diagnosis and inappropriate treatment, fitting the High severity category.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (Lot 565). The recall involves 560 kits with worldwide distribution, including the United States and over 40 other countries.
The kits have potential for falsely elevated mold allergen-specific IgE reactivity when testing quality control materials and patient samples. This may result in false reactive (positive) test results that do not reflect actual allergy status.
These diagnostic kits are designed to measure allergen-specific IgE in serum as an aid in diagnosing allergic disorders. False reactive results could lead to incorrect diagnoses and inappropriate clinical decision-making based on inaccurate test outcomes.
The recalled product
- Product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI:-DI: (01)00630414278735(10)565(17)20221130 Kit Lot 565
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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