Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0666-2026·Announced 2025-12-03

Liquid biopsy reports recalled for omitting the companion diagnostic claims page

Foundation Medicine is recalling 18 FoundationOne Liquid CDx reports that were sent to customers without the companion diagnostic Claims Page.

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: Scored 2 because the record cites an omitted report page that the firm supplied within seven days, with no stated clinical consequence or reported harm.

Plain-English summary

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0, from Foundation Medicine, is the subject of a recall.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. The firm states claims pages were distributed via amended reports within 7 days of the issue occurrence.

The recall covers 18 units, of which the record lists 17 in the United States and 1 outside it, identified by test number. Distribution was nationwide in the United States including Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Minnesota, Missouri, Mississippi, Montana and North Carolina. The FDA has classified the action as Class II.

The enforcement record describes a missing report page that was subsequently supplied, and reports no injuries. Sites should follow Foundation Medicine's instructions.

The recalled product

Product: IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15…
Manufacturer: B Braun Medical Inc
Category: Medical Device — Diagnostic test
Hazard: incomplete-report
companion-diagnostic
documentation
Affected units: 23,160

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 (3)

1. Catalog Number: 490487
Primary UDI-DI: 04046955086856
Unit of Dose UDI-DI: 04046955086849.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 116 recalled by B Braun Medical 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 116 products in this recall →

Same manufacturer · B Braun Medical Inc

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