LYFO DISK Streptococcus Pneumoniae Culture Kit Recalled for Bacterial Contamination
Microbiologics Inc is recalling LYFO DISK Streptococcus pneumoniae microorganism culture kits (lot 947-126-1) distributed worldwide due to potential contamination with E. coli, Staphylococcus epidermidis, and S. warneri.
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: This is an FDA Class II recall for potential contamination with E. coli, a high-risk pathogen. Since no illnesses or injuries are reported and the hazard is theoretical, the severity is classified as High per FDA guidelines.
Plain-English summary
LYFO DISK Streptococcus pneumoniae is a lyophilized microorganism culture kit manufactured by Microbiologics Inc. Each kit contains 6 lyophilized microorganism pellets packaged in a resealable vial with desiccant. The affected lot (947-126-1, catalog number 0947L, UDI 10845357022964) consisted of 42 units.
The recall was issued because the LYFO DISK kits are subject to potential contamination with Escherichia coli, Staphylococcus epidermidis, and Staphylococcus warneri. This contamination could compromise the microorganisms' viability and the reliability of laboratory results when using these products.
The affected lot was distributed worldwide, including to customers throughout the United States, Canada, Mexico, Brazil, Australia, Europe, Asia-Pacific, the Middle East, Africa, and South America.
LYFO DISK microorganism culture kits are quality control products used in laboratory and clinical settings. Contamination with pathogenic or non-target bacteria could affect the accuracy of microbiological testing and quality assurance protocols.
The recalled product
- Product
- LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorg
- Manufacturer
- Microbiologics Inc
- Affected units
- 42
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: 0947L
- Lot Number: 947-126-1
- UDI: 10845357022964
Distribution
Part of a larger recall action
This product is one of 3 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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