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Recall Observatory FDA recall evidence

Device 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.

Z-0583-2022

October 01, 2020

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 89391
Status
Terminated
Classification
Class II
Quantity
42 units
Official record key
device-enforcement:Z-0583-2022

Official wording

Reason: Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.

Code information: Catalog Number: 0947L, Lot Number: 947-126-1, UDI: 10845357022964

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, FRANCE, GEORGIA, GERMANY, GUATAMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, VIETNAM.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination with Escherichia coli