KWIK-STIK recallZ-0546-2022 · Microbiologics Inc · initiated Dec 16, 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
The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
FDA root cause category: Employee error
What the company is doing
Microbiologics notified customers on about 12/16/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to update records with the correct expiration date of 07/31/2022 and keep the letter for their records. Questions or concerns can be directed to Recall Support team at 320.229.7073 or [email protected].
Recall details
- Recall number
- Z-0546-2022
- Status
- Terminated
- Initiated by the company
- Dec 16, 2020
- Recalling firm
- Microbiologics Inc
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.
Product description
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Code information (models, lots, serial numbers)
Main Product Codes: Catalog Number: 8164, Lot Number: 8164-78, UDI: 70845357028623, Expiration date: 09/30/2021. Affected Component Codes: Catalog Number: 0243U, Lot Number: 243-48-5, UDI: 10845357004083, Expiration Date on Label: 07/31/2020, Correct Expiration Date: 07/31/2022.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- QC Sets and Panels: KWIK-STIK™ 8164Microbiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
- KWIK-STIK™ 0243UMicrobiologics 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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