Diagnostic Kit Recall: Falsely Elevated Mold Allergen Test Results
Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.
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: This is a medical device diagnostic kit with potential for false positive test results affecting clinical diagnosis. No injuries or illnesses have been reported. As a Class II FDA recall involving risk of harm to diagnosis accuracy but no reported adverse events, this qualifies as High severity per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 5,193 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (kit lots 826, 830, 831, 832, and 833) due to the potential for falsely elevated mold allergen reactivity readings. The kits measure allergen-specific IgE in blood serum to aid in diagnosing IgE-mediated allergic disorders.
The affected kits may produce falsely elevated results for mold allergen reactivity in both quality control materials and patient samples, potentially resulting in false positive test results and incorrect mold allergy diagnoses.
The affected kits have been distributed worldwide across the United States and 58 other countries. Healthcare laboratories currently using these kit lots should discontinue use and contact Siemens Healthcare Diagnostics for replacement options.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 5,193
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 (9)
- UDI:-DI: (01)00630414962269(10)826(17)20221130
- (01)00630414962269(10)830(17)20221130
- (01)00630414962269(10)831(17)20221130
- (01)00630414962269(10)832(17)20221130
- (01)00630414962269(10)833(17)20221130. Kit Lots: 826
- 830
- 831
- 832
- 833
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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