LYFO Disk Quality Control Product Recalled for Organism Mislabeling
Microbiologics Inc recalls LYFO Disk lot 983-40-3 because it is labeled as Candida tropicalis but actually contains Yersinia enterocolitica. The mislabeling may cause laboratory quality control failures and delayed test results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III medical device recall involving a labeling error. No illnesses, injuries, or deaths have been reported. The impact is operational—potential laboratory quality control failures and delayed results—rather than direct patient safety harm. Per the rubric, labeling errors without reported illness are scored as Moderate (2).
Plain-English summary
Microbiologics Inc is recalling LYFO Disk (Catalog #0983L), a quality control product used in microbiology laboratories. Lot number 983-40-3 is labeled as containing Candida tropicalis but actually contains Yersinia enterocolitica instead.
The labeling error poses a risk to laboratory quality control processes. Users relying on the product for quality assurance testing may receive incorrect results, potentially invalidating their quality control procedures and requiring testing to be repeated, resulting in delayed test results.
The affected lot was distributed nationwide to three consignees located in Colorado, Georgia, and Ohio. The lot expires on February 11, 2016.
If you have received this product, do not use it for quality control testing. Contact Microbiologics Inc for further instructions regarding return or replacement of the affected lot.
The recalled product
- Product
- LYFO Disk
- Manufacturer
- Microbiologics Inc
- Affected units
- 3
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 (3)
- Catalog Number 0983L
- UDI: 10845357023930
- Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Distribution
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