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Recall Observatory FDA recall evidence

Device product

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

Z-0511-2022

December 16, 2020

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 89285
Status
Terminated
Classification
Class II
Quantity
59 kits
Official record key
device-enforcement:Z-0511-2022

Official wording

Reason: Contamination with S. epidermidis

Code information: 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;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Contamination with S. epidermidis