Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.
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: The recall involves a medical device with a potential for inaccurate results due to missing critical safety information (biotin interference levels) in the instructions for use. While no illnesses or injuries are reported, the risk of harm from misdiagnosis places this at High severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. has initiated a recall affecting certain assays used with the IMMULITE 2000 and IMMULITE 2000 XPi TG systems. The affected products include 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12 assays. The recall also encompasses related tests on the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, and ADVIA Centaur aHBcM platforms.
The core issue is that the instruction for use documents for these specific assays do not currently list the concentration of biotin that does not interfere with test results. Consequently, these assays are susceptible to interference from biotin. If patients have taken biotin supplements, the test results may be inaccurate, potentially leading to misdiagnosis or inappropriate medical decisions.
The distribution pattern for these recalled items includes locations in the United States as well as Canada, Mexico, and Thailand. Healthcare providers and laboratories using these specific IMMULITE and related platform assays should review their inventory against the lot codes provided in the official recall notice and follow FDA guidance for handling potentially affected samples.
The recalled product
- Product
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
- 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 (4)
- TG
- TG (IMMULITE/IMMULITE 1000
- LKTY1(D))
- (IMMULITE 2000/IMMULITE 2000 XPi
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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