Food, drugs, devices › Microbiologics Inc
Device recall: Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify
FDA enforcement event 86574 is a device recall by Microbiologics Inc of Saint Cloud, MN, initiated 8 Oct 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 3 Nov 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
"Strain should be VIM-1 positive but is confirmed to be VIM-1 negative."
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0402-2021 | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate. | 46 units | Class II | Terminated | 11 Nov 2020 |
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: "Strain should be VIM-1 positive but is confirmed to be VIM-1 negative."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Nov 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.