KWIK-STIK recallZ-1125-2022 · Microbiologics Inc · initiated May 6, 2022
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
Labeling error.
FDA root cause category: Labeling mix-ups
What the company is doing
The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form.
Recall details
- Recall number
- Z-1125-2022
- Status
- Terminated
- Initiated by the company
- May 6, 2022
- Recalling firm
- Microbiologics Inc
- Quantity
- 8 units
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.
Product description
KWIK-STIK" plus: Clostridium perfringens
Code information (models, lots, serial numbers)
catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 0801UMicrobiologics 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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