QC Sets and Panels: KWIK-STIK 2 Pack recallZ-2576-2023 · Microbiologics Inc · initiated Aug 14, 2023
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
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
FDA root cause category: Packaging process control
What the company is doing
Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed.
Recall details
- Recall number
- Z-2576-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 14, 2023
- Posted by the FDA
- Sep 11, 2023
- Recalling firm
- Microbiologics Inc
- Quantity
- 4 units
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- US Nationwide distribution in the states of MN, PA, TN, TX.
Product description
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Code information (models, lots, serial numbers)
UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- QC Sets and Panels: KWIK-STIK™ 2 Pack 5065PMicrobiologics 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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