Siemens IMMULITE 2000 Italian Cypress Allergy Test Recall
Siemens is recalling specific lots of the IMMULITE 2000 Italian Cypress 3g Allergy test because they fail to meet shelf-life stability specifications.
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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a failure to meet shelf-life stability specifications, which is a quality control issue rather than a direct acute injury risk like a structural defect or high-risk pathogen.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy test kits. The affected products are Catalog # T23L4 (40 test) with Siemens Material Number (SMN) 10386079. The recall involves Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015).
The recall is being issued because the affected lots fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the product label. This is an in vitro diagnostic (IVD) device used for the quantitative measurement of allergen-specific IgE in human serum.
The affected kits were distributed worldwide, including in the United States (Florida, New Mexico, and New York) and numerous international locations. Domestic distribution included 17 kits, while foreign distribution included 1,549 kits. Users should check their inventory for these specific lot numbers and expiration dates.
The recalled product
- Product
- IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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)
- Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)
Distribution
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