Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1678-2018·Announced 2018-05-16

Siemens IMMULITE CEA Assay Recalled for Biotin Interference Risk

Siemens Healthcare Diagnostics is recalling IMMULITE CEA assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.

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, and the hazard involves a labeling omission regarding biotin interference thresholds. No illnesses or injuries are reported, and the risk is related to test accuracy rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE /IMMULITE 1000 CEA assay. The recall is due to the fact that the concentration of biotin that does not interfere with the test is not currently listed in the instruction for use. This omission means the assay is susceptible to interference from biotin, which could impact the accuracy of the results.

The affected products include the IMMULITE /IMMULITE 1000 CEA assay with lot codes 0355, 0356, and 0357. 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 lots and contact Siemens Healthcare Diagnostics for further instructions on how to proceed. This recall is a precautionary measure to ensure that patients are not exposed to inaccurate test results due to biotin interference.

The recalled product

Product: IMMULITE ¿ /IMMULITE ¿ 1000 CEA
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: biotin-interference
mis-labeling

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 (6)

CEA
CEA (IMMULITE/IMMULITE 1000
LKCE1)
(IMMULITE 2000/IMMULITE 2000 XPi
LKCE2
LKCE6) Lot codes: 0355 0356 0357

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.

See all 24 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · biotin interference