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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0584-2022 |
| Event ID | 89391 |
| Event 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. |
| Product Type | Devices |
| 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, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, VIETNAM. |
| Quantity | 11 units |
| Recall Reason | Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. |
| Device Classification | 20220216 |
| Device Code Info | Catalog Number: 5193P; Lot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021); UDI: 70845357030718 |
| Center Classification Date | 20220208 |
| Recall Initiation Date | 20201001 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
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