LYFO-DISK Microbiological Quality Control Material May Fail to Function
Microbiologics Inc is recalling LYFO-DISK quality control materials that may fail to properly recover the target microorganism, potentially compromising laboratory test validation procedures.
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: This Class II medical device recall involves a laboratory quality control material with no reported illnesses or injuries. The product's failure to function properly presents a functional hazard in a controlled laboratory environment, fitting the profile of a voluntary precautionary recall.
Plain-English summary
Microbiologics Inc is recalling LYFO-DISK, a lyophilized microbiological quality control material derived from Mycobacterium canis (ATCC 36299). The affected products are packaged as 6-packs (REF 0894K) and 2-packs (REF 0894P), with all lots bearing REF 894-76 designation impacted.
The recall was initiated because these quality control materials may result in failure to recover the target microorganism. This failure could prevent proper validation of laboratory test procedures that rely on this quality control standard.
The affected products have been distributed worldwide, including throughout the United States and to France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Vietnam, Brazil, Japan, Malaysia, and Costa Rica.
Laboratories and quality control operations that have received these materials should discontinue use and contact Microbiologics Inc for replacement product or additional guidance.
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
- Hazard
- product-malfunction
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.
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