KWIK-STIK recallZ-0641-2022 · Microbiologics Inc · initiated Mar 25, 2013
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
Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
FDA root cause category: Labeling mix-ups
What the company is doing
Microbiologics notified customers on 03/25/2013 via letter titled "Important Medical Device Correction". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (KWIK-STIK" 01023P, Lot# 1023-05-7), it is recommended that the customer destroys the product. Microbiologics shall replace the destroyed product upon confirmation of destruction. Questions or concerns can be directed to the Customer Service Manager at 320.229.7057.
Recall details
- Recall number
- Z-0641-2022
- Status
- Terminated
- Initiated by the company
- Mar 25, 2013
- Recalling firm
- Microbiologics Inc
- Quantity
- 10 units
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
Product description
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Code information (models, lots, serial numbers)
Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 01023UMicrobiologics 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.
How recalls are matched to devices · Editorial policy · Report an error on this page