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Microbiologics Inc Recall 89391

Description: QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.

Microbiologics Inc Recall 89391 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0584-2022
Event ID89391
Event DescriptionQC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.
Product TypeDevices
DistributionWorldwide 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.
Quantity11 units
Recall ReasonPotential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Device Classification20220216
Device Code InfoCatalog Number: 5193P; Lot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021); UDI: 70845357030718
Center Classification Date20220208
Recall Initiation Date20201001
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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