LYFO DISK Streptococcus (Microbiologics) – Contamination Risk (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements.
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog Number: 0947L, Lot Number: 947-126-1, UDI: 10845357022964
Products Sold
Catalog Number: 0947L, Lot Number: 947-126-1, UDI: 10845357022964
Microbiologics Inc is recalling LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK m due to Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
Recommended Action
Per FDA guidance
Microbiologics notified customers on about 10/01/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions included the following: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3. COMPLETE the response form provided; 4. RETURN the response form to recall@microbiologics.com; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026