KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
FDA Recall Z-0511-2022 · Posted None
Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2020-12-16
Date Terminated2022-07-07
Product Quantity59 kits
Reason for Recall
Contamination with S. epidermidis
Firm Action
The recalling firm issued letters beginning 12/16/2020 to their consignees explaining the reason for recall and that due to the distinct morphology of Microsporum canis, it is possible to distinguish between the 2 colonies and select the correct microorganism from an agar plate for testing. The consignee was provided the instructions to review their lab procedures to understand how this information affects their usage, use or discard depending on their lab procedures and how this information affects their usage, complete the response form and return it to the firm. The letter is to kept for their records and the firm is to be contacted for a replacement kit if needed. The response form was to indicate the consignee has acknowledged receipt of the information, has updated their records, and to report the number of kits on hand. If the consignee has discarded or destroyed individual units, they are to indicate the quantity needed for replacement.
Root Cause
Material/Component Contamination
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.