Siemens Allergen Test Kit Recall: False Positive Mold Results
Siemens is recalling IMMULITE 2000 allergen test kits that may produce false positive results for mold allergies in both quality control and patient samples.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall with no reported illnesses or injuries. The defect involves diagnostic accuracy (false positive results) rather than direct patient harm. Per the rubric, precautionary recalls without reported illness are scored as Moderate.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T). These in vitro diagnostic kits are used to measure allergen-specific IgE in human serum as an aid in diagnosing IgE-mediated allergic disorders. Affected lot numbers are D830, D831, D832, and D833. A total of 1000 kits were recalled.
The recall is due to a potential defect that may cause falsely elevated specific IgE mold allergen reactivity in quality control materials and patient samples. This defect may result in false positive results that could affect the accuracy of allergy diagnosis.
The kits were distributed worldwide, including throughout the United States and to numerous international locations including Argentina, Australia, Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Japan, Latvia, Lithuania, Macedonia, Mexico, Netherlands, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, Uruguay, and Uzbekistan.
The recalled product
- Product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,000
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 (7)
- UDI-DI (01)00630414982939(10)D830(17)20221130
- (01)00630414982939(10)D831(17)20221130
- (01)00630414982939(10)D832(17)20221130
- (01)00630414982939(10)D833(17)20221130. Lot Numbers: D830
- D831
- D832
- D833
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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