The Recall Desk
ModerateFDA (Devices)·Z-0986-2026·Announced 2025-12-31

Campylobacter LYFO DISK controls recalled over failure to recover the organism

Microbiologics is recalling LYFO DISK units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

What this means for you

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 a control material that may not recover the target organism, with no stated consequence or reported harm.

Plain-English summary

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, catalog number 0325L, is being recalled by Microbiologics Inc.

Affected units may fail to recover the target microorganism, Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

The record lists 1 unit, with 16 additional units added on 12/22/25, carrying UDI-DI 10845357006476 across lots 325-120-5, 325-119-3 and 325-119-6. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.

The record describes a failure of the control material to recover the organism and states no further consequence or reported injuries. Laboratories should follow Microbiologics' instructions.

The recalled product

Product
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Manufacturer
Microbiologics Inc
Category
Medical Device — Laboratory control material
Hazard

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 (4)

  • UDI-DI: 10845357006476
  • Lot Numbers: 325-120-5
  • Additional lots added 12/22/25: 325-119-3
  • 325-119-6

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Microbiologics 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 3 products in this recall →

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