Food, drugs, devices › Microbiologics Inc
Device recall: KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD contro
FDA enforcement event 89380 is a device recall by Microbiologics Inc of Saint Cloud, MN, initiated 24 Feb 2021 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. 3% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 11 Jul 2022. 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
"Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10."
Distribution
"US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0544-2022 | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls. | 47 packs (94 units) | Class III | Terminated | 9 Feb 2022 |
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: "Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10."
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 distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Jul 2022. "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.