KWIK-STIK recallZ-0402-2021 · Microbiologics Inc · initiated Oct 8, 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
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
FDA root cause category: Under Investigation by firm
What the company is doing
Communication was extended to consignees that received product directly from the recalling firm. Distributors outside of the United States will be contacted via email, and if follow-up is required, the recalling firm's international sales team will contact the distributor to ensure that this communication is extended to their end-users. The recalling firm will work with the European Authorized Representative to coordinate all field safety corrective actions for consignees in the EU. The recalling firm will conduct effectiveness checks by contacting 100% of consignees that do not respond to the correspondence. This will be completed via phone or email.
Recall details
- Recall number
- Z-0402-2021
- Status
- Terminated
- Initiated by the company
- Oct 8, 2020
- Recalling firm
- Microbiologics Inc
- Quantity
- 46 units
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.
Product description
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.
Code information (models, lots, serial numbers)
Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 01245UMicrobiologics 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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