Siemens IMMULITE 2000 Allergy IgE Kit Recalled for Biotin Interference
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Allergy specific IgE Universal Kits because biotin interference is not documented in the instructions for use.
What this means for you
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a lack of documentation regarding biotin interference, which is a theoretical risk of inaccurate results rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit. The recall is due to the fact that the concentrations of biotin that do not interfere with the test are not currently listed in the instructions for use. The source text indicates that these assays are susceptible to interference from biotin.
The affected products include specific lot numbers for the 3g Allergy Specific IgE kit, ranging from 461 to 476 and D463 to D483. The products were distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand.
Healthcare providers and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. Patients who have had these tests performed should consult their healthcare provider regarding the potential impact of biotin interference on their results.
The recalled product
- Product
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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)
- 3g Allergy specific IgE Universal kit
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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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