FDA Recalls Microbiologics LYFO-DISK M. Canis Lab Control Organisms
Microbiologics Inc. is recalling LYFO-DISK M. Canis and KWIK-STIK quality control organisms (REF 894-76 lots 894-76-4 and 894-76-6) because they may fail to recover the target microorganism, affecting laboratory testing integrity. Products distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II with no reported illnesses or injuries. This is a risk-of-harm product where the failure to recover the target microorganism could compromise laboratory quality control testing integrity. Injury has not yet been reported, placing it at score 3 per the rubric.
Plain-English summary
Microbiologics Inc. is recalling LYFO-DISK M. Canis freeze-dried organisms and related KWIK-STIK products. The recall affects all lots with REF 894-76, including lot numbers 894-76-4 and 894-76-6, with product reference numbers 0894P, 0894K, and 0894L.
These products may result in failure to recover the target microorganism, according to the FDA notice. LYFO-DISK and KWIK-STIK are laboratory quality control organisms used in testing and validation procedures. When the organism cannot be recovered, laboratory quality control testing cannot function as intended.
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 testing facilities using these products may have received affected lots.
Laboratories and testing facilities should check their inventory for the affected lot and reference numbers. If you possess products with lot numbers 894-76-4 or 894-76-6 (REF 0894P, 0894K, or 0894L), contact Microbiologics Inc. for guidance regarding any quality control testing performed with these organisms.
The recalled product
- Product
- LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
- Manufacturer
- Microbiologics Inc
- Hazard
- viability-failure
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.
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