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
Product summary
- 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
contamination with Escherichia coli