KWIK-STIK 2 Pack, Catalog #0894P recallZ-0511-2022 · Microbiologics Inc · initiated Dec 16, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Contamination with S. epidermidis
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0511-2022
- Status
- Terminated
- Initiated by the company
- Dec 16, 2020
- Recalling firm
- Microbiologics Inc
- Quantity
- 59 kits
- Product code
- JTR
- FDA submissions
- K861022
- 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.
Product description
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Code information (models, lots, serial numbers)
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;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 0947UMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA2 recalls0 reports
- LYFO DISK™ 0947LMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page