Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1681-2018·Announced 2018-05-16

Siemens IMMULITE Gastrin Assay Recalled for Biotin Interference

Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.

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 corresponds to a moderate severity score. The hazard is a labeling omission regarding biotin interference limits, which is a documentation issue rather than a direct physical defect or reported injury.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000/IMMULITE 2000 XPi Gastrin assays. 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 instruction for use.

The source text indicates that these assays are susceptible to interference from biotin. This recall is part of a broader issue affecting several other Siemens assays, including Dimension Vista and ADVIA Centaur products, where biotin interference limits are not documented.

The affected products were distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The specific lot codes involved are 251, 252, 253, 254, and 255. Users of these medical devices should consult the manufacturer for further instructions on handling the recalled units.

The recalled product

Product: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
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 (5)

Gastrin
Gastrin (IMMULITE/IMMULITE 1000
LKGA1)
(IMMULITE 2000/IMMULITE 2000 XPi
LKGA2) Lot codes: 251 252 253 254 255

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