LYFO-DISK M. canis single packs may fail to recover the organism
LYFO-DISK M. canis preparations, REF 0894L, are being recalled because they may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
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 0894L, UDI/DI 10845357021967, is being recalled. Affected lot numbers are 894-76-4 and 894-76-6. The source does not state a quantity.
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 0894L
- Manufacturer
- Microbiologics Inc
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 (2)
- 1) 0894L: UDI/DI 10845357021967
- Lot Numbers 894-76-4 and 894-76-6
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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