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.
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: 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
- 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.
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