The Recall Desk
ModerateFDA (Devices)·Z-2194-2025·Announced 2025-08-06

LYFO-DISK M. canis multipacks may fail to recover the organism

LYFO-DISK M. canis preparations in 6-pack and 2-pack formats are being recalled because they may result in failure to recover the target microorganism. 32 units are affected.

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: FDA Class II recall of a laboratory reference organism preparation that may not grow as expected, with no patient result or clinical consequence stated.

Plain-English summary

LYFO-DISK, M. canis derived from ATCC 36299, packaged as REF 0894K (6-pack, UDI/DI 30845357021954) and REF 0894P (2-pack, UDI/DI 20845357021940), is being recalled. The action covers 32 units, with affected lots including 894-76-81.

The stated reason is that KWIK-STIK REF numbers 0894P and 0894K and LYFO DISK 0894L may result in failure to recover the target microorganism, and all lots of REF 894-76 are impacted. The FDA classified the action as Class II. The source does not describe a patient consequence.

Distribution was worldwide, including nationwide in the United States and to France, Colombia and the Philippines among other countries.

Laboratories should identify affected stock using the REF, UDI/DI and lot numbers above and follow the instructions issued by the manufacturer.

The recalled product

Product
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Manufacturer
Microbiologics Inc
Category
Medical Device — Microbiology quality control
Hazard
Affected units
32

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)

  • 1) 0894K: UDI/DI 30845357021954
  • Lot Numbers: 894-76-81
  • 2) 0894P: UDI/DI 20845357021940
  • Lot Numbers: 894-76-21
  • 894-76-51
  • 894-76-52.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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