Microbiological Reference Products Recalled for Bacterial Contamination
Microbiologics Inc is recalling KWIK-STIK and LYFO DISK microbiological reference products contaminated with Staphylococcus epidermidis. Fifty-nine kits were distributed to multiple U.S. states and countries.
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 a risk-of-harm medical device product (microbiological reference material) with contamination by a pathogenic organism, classified as FDA Class II. No illnesses or injuries have been reported, which limits the maximum score to 3 per the rubric.
Plain-English summary
Microbiologics Inc is recalling three microbiological reference products: KWIK-STIK 2 Pack (Catalog #0894P), KWIK-STIK 6 Pack (Catalog #0894K), and LYFO DISK (Catalog #0894L). These products are intended to contain Microsporum canis but have been found to be contaminated with Staphylococcus epidermidis.
A total of 59 kits have been distributed to thirteen U.S. states and sixteen countries. In the U.S., distribution occurred in California, Iowa, Illinois, Louisiana, Massachusetts, Michigan, New York, Pennsylvania, South Dakota, Tennessee, Virginia, Wisconsin, and West Virginia. International distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, South Africa, and United Kingdom. No government or military distribution took place.
Customers who have received these products should discontinue use. No illnesses or injuries associated with this contamination have been reported.
The recalled product
- Product
- KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
- Manufacturer
- Microbiologics Inc
- Affected units
- 59
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 (11)
- KWIK-STIK 2 Pack - Catalog#: 0894P
- Lot #: 894-68-3
- Exp. 6/30/2022
- 894-68-4
- UDI: 20845357022947
- KWIK-STIK 6 Pack - Catalog#: 0894K
- Lot #: 894-68-1
- UDI: 30845357022951
- LYFO DISK - Catalog#: 0894L
- Lot #: 894-68-2
- UDI: 10845357022964
Distribution
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