CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

Kwik-stik, Quality control kit for culture media recalled

Microbiologics is recalling Kwik-stik, Quality control kit for culture media, Vibrio parahaemolyticus derived from. The recall was initiated on 13 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 30845357020018; Lot Number: 818-111-7

Quantity recalled5 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0876-2026
FDA event ID: 97987
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Ongoing
Recall initiated: 13 Nov 2025
FDA classified: 2 Dec 2025
Reported: 10 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

13 Nov 2025	Recall initiated by company
2 Dec 2025	Classified by FDA	+19 days
10 Dec 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

Where it was distributed

International distribution to the countries of UAE, China, Singapore, Kazakhstan,

Questions about this recall

Why was it recalled?

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

Which lots are affected?

UDI-DI: 30845357020018; Lot Number: 818-111-7

Where was it sold?

International distribution to the countries of UAE, China, Singapore, Kazakhstan,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Microbiologics

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31 Dec 2025Device	CLASS II	Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
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