KWIK-STIK recallZ-0876-2026 · Microbiologics Inc · initiated Nov 13, 2025
Open, Classified
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
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Recall notification letter dated 11/13/25 was sent to customers. INSTRUCTIONS: 1.CONTACT END USERS who have received or may have received the affected items above and provide them with the Customer Communication and Customer Response Forms. 2.COMPLETE the Distributor Response Form provided. 3.RETURN the response forms to [email protected]. 4.KEEP this letter for your records. 5.CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns. Collect calls may be made.
Recall details
- Recall number
- Z-0876-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 13, 2025
- Posted by the FDA
- Dec 2, 2025
- Recalling firm
- Microbiologics Inc
- Quantity
- 5 units
- Product code
- JTR
- Distribution
- International distribution to the countries of UAE, China, Singapore, Kazakhstan,
Product description
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Code information (models, lots, serial numbers)
UDI-DI: 30845357020018; Lot Number: 818-111-7
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 0818UMicrobiologics 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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