Microbiologics Inc: 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 hydra

Is my product affected?

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

• UPC 70845357030718

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

What happened

Microbiologics Inc. is recalling KWIK-STIK 2 Pack QC Sets and Panels (Catalog Number 5193P) due to potential contamination with Escherichia coli, Staphylococcus epidermidis, and S. warneri. The affected products include Lot Numbers 5193-10 (expiration date 09/30/2021) and 5193-11 (expiration date 04/30/2021), with a total of 11 units recalled. The products were distributed worldwide and throughout the United States, including Puerto Rico and numerous countries including Canada, Australia, China, India, and many others.

The recall record does not specify a remedy or recommended action for consumers who may have obtained these products.

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: 11 units Lot/code info: Catalog Number: 5193P; Lot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021); UDI: 70845357030718

Source

Official record: FDA (Device enforcement) ↗

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

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