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FDA (Device enforcement)Recalled 2020-12-16closedclass ii

Microbiologics Inc: KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.

Is my product affected?

KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.

  • UPC 20845357022947
  • UPC 30845357022951
  • UPC 10845357022964

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

What happened

Microbiologics Inc is recalling three products used for microbiological testing: KWIK-STIK 2 Pack (Catalog #0894P), KWIK-STIK 6 Pack (Catalog #0894K), and LYFO DISK (Catalog #0894L). These products, which contain Microsporum canis derived from ATCC 36299, were found to be contaminated with S. epidermidis. A total of 59 kits were affected across specific lot numbers, all with expiration dates of 6/30/2022.

The contaminated products were distributed to thirteen U.S. states (California, Iowa, Illinois, Louisiana, Massachusetts, Michigan, New York, Pennsylvania, South Dakota, Tennessee, Virginia, Wisconsin, and West Virginia) and sixteen countries internationally. The recall source does not specify a remedy or corrective action for consumers who may have received these products.

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

Hazard

Contamination with S. epidermidis

Details from the source

Reason for recall: Contamination with S. epidermidis Distribution: Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, South Africa, and United Kingdom. Quantity: 59 kits Lot/code info: KWIK-STIK 2 Pack - Catalog#: 0894P, Lot #: 894-68-3, Exp. 6/30/2022, 894-68-4, Exp. 6/30/2022, UDI: 20845357022947; KWIK-STIK 6 Pack - Catalog#: 0894K, Lot #: 894-68-1, Exp. 6/30/2022, UDI: 30845357022951; LYFO DISK - Catalog#: 0894L, Lot #: 894-68-2, Exp. 6/30/2022, 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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