Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1680-2018·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. The hazard involves a labeling omission regarding biotin interference, which is a moderate risk of inaccurate test results rather than a direct physical injury or high-risk pathogen.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE /IMMULITE 1000 Gastrin 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.

The source text indicates that the IMMULITE Gastrin assay is susceptible to interference from biotin. This issue affects the specific lot codes 0345, 0346, and 0347 for the Gastrin assay. The product was distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand.

Consumers and healthcare providers should stop using the affected IMMULITE Gastrin assays and contact Siemens Healthcare Diagnostics for further instructions or replacement.

The recalled product

Product: IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
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: Gastrin Lot # 0345 0346 0347

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