CLASS III ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
Kwik-stik, ANA (3 Strains) QC Set recalled by Microbiologics
Microbiologics is recalling Kwik-stik, ANA (3 Strains) QC Set, distributed nationwide in the US. The recall was initiated on 14 Aug 2023 and the FDA has classified it as Class III.
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-2576-2023
- FDA event ID
- 92878
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 14 Aug 2023
- FDA classified
- 11 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Aug 2023 | Recall initiated by company | |
| 11 Sep 2023 | Classified by FDA | +28 days |
| 20 Sep 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Product as listed by the FDA
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Where it was distributed
US Nationwide distribution in the states of MN, PA, TN, TX.
Questions about this recall
Why was it recalled?
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Which lots are affected?
UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
Where was it sold?
US Nationwide distribution in the states of MN, PA, TN, TX.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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