KWIK-STIK recallZ-0544-2022 · Microbiologics Inc · initiated Feb 24, 2021
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
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
FDA root cause category: Labeling mix-ups
What the company is doing
Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3.COMPLETE the response form provided; 4. RETURN the response form to [email protected]; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or [email protected].
Recall details
- Recall number
- Z-0544-2022
- Status
- Terminated
- Initiated by the company
- Feb 24, 2021
- Posted by the FDA
- Jan 31, 2022
- Recalling firm
- Microbiologics Inc
- Quantity
- 47 packs (94 units)
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
Product description
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Code information (models, lots, serial numbers)
Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 0323UMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 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.
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