Siemens Recalls Immulite Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
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 is FDA Class II, but the hazard involves a risk of inaccurate diagnostic results due to biotin interference. While no illnesses are reported, incorrect test results for critical markers like Thyroglobulin or Vitamin B12 pose a significant risk of harm if misinterpreted clinically.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of IMMULITE assays, including 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12. The recall also affects the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, and ADVIA Centaur aHBcM.
The issue stems from the instructions for use for these products not currently listing the concentration of biotin that does not interfere with test results. Consequently, these assays are susceptible to interference from biotin, which may lead to inaccurate patient test results.
The affected products were distributed nationwide in the United States and in Canada, Mexico, and Thailand. The recall covers lot codes 0289, 0290, 0291, D0289, D0290, and D0291 for the IMMULITE/IMMULITE 1000 (LKTY1(D)) and IMMULITE 2000/IMMULITE 2000 XPi (LKTY2(D)) systems.
Healthcare providers and laboratories using these assays should be aware of this potential interference when interpreting biotin-related tests.
The recalled product
- Product
- IMMULITE ¿ /IMMULITE ¿ 1000 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 (5)
- TG
- TG (IMMULITE/IMMULITE 1000
- LKTY1(D))
- (IMMULITE 2000/IMMULITE 2000 XPi
- LKTY2(D)) Lot codes: 0289 0290 0291 D0289 D0290 D0291
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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