Microbiologics Inc: KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophi

Is my product affected?

KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a lamin

• UPC 20845357022947
• UPC 30845357022951

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

What happened

Microbiologics Inc. is recalling KWIK-STIK products containing Streptococcus pneumoniae in both 2-pack and 6-pack configurations due to potential contamination with S. epidermidis, E. coli, and S. warneri. The recall affects 271 units distributed worldwide across numerous U.S. states and countries including Canada, Australia, Brazil, China, and many others.

The affected products have specific catalog and lot numbers: Catalog Number 0947P with Lot Numbers 947-126-2 and 947-126-4, and Catalog Number 0947K with Lot Number 947-126-3. The source document does not specify a remedy for affected consumers.

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

Hazard

Potential contamination with S. epidermidis E. coli and S. warneri.

Details from the source

Reason for recall: Potential contamination with S. epidermidis E. coli 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: 271 units total Lot/code info: a. Catalog Number: 0947P; Lot Number: 947-126-2, 947-126-4; UDI: 20845357022947. b. Catalog Number: 0947K; Lot Number: 947-126-3; UDI: 30845357022951

Source

Official record: FDA (Device enforcement) ↗

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

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