Food, drugs, devices › Microbiologics Inc
Device recall: KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
FDA enforcement event 92878 is a device recall by Microbiologics Inc of Saint Cloud, MN, initiated 14 Aug 2023 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 2% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Microbiologics Inc has 43 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Microbiologics Inc, Saint Cloud, MN.
Reason for recall
"One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis."
Distribution
"US Nationwide distribution in the states of MN, PA, TN, TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2576-2023 | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | 4 units | Class III | Ongoing | 20 Sep 2023 |
Context
Other enforcement events for Microbiologics Inc
All 43 events for Microbiologics Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of MN, PA, TN, TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.