CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Kwik-stick, Quality control kit for culture media recalled
Microbiologics is recalling Kwik-stick, Quality control kit for culture media, distributed nationwide in the US. The recall was initiated on 27 May 2025 and the FDA has classified it as Class II.
Check your package
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-1957-2025
- FDA event ID
- 96974
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 May 2025
- FDA classified
- 11 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 27 May 2025 | Recall initiated by company | |
| 11 Jun 2025 | Classified by FDA | +15 days |
| 18 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
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-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Where it was distributed
US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
Questions about this recall
Why was it recalled?
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Which lots are affected?
01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21
Where was it sold?
US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
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.
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