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FDA (Device enforcement)Recalled 2020-10-01closedclass ii

Microbiologics Inc: 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 microor

Is my product affected?

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

  • UPC 10845357022964

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc is recalling LYFO DISK Streptococcus pneumoniae products due to potential contamination with Escherichia coli, Staphylococcus epidermidis, and S. warneri. The affected product is packaged in resealable vials containing lyophilized microorganisms and is identified by Catalog Number 0947L, Lot Number 947-126-1, and UDI 10845357022964. A total of 42 units were distributed worldwide.

The recalled product was distributed nationwide across the United States and to multiple countries including Canada, Australia, China, India, and many others. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. Distribution: 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, JA Quantity: 42 units Lot/code info: Catalog Number: 0947L, Lot Number: 947-126-1, UDI: 10845357022964

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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