KWIK-STIK Microbiological Set (Microbiologics) – Contamination (2020)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Contamination with S. epidermidis

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

CA, IL, IA, LA, MA, MI, NY, PA, SD, TN, VA, WV, WI