Microbiologics Inc

FDA recalling firm · 43 enforcement events · 66 product records · 2012–2025 · MN

Microbiologics Inc has 43 FDA enforcement events on this register (66 product records) between 2012 and 2025: 43 device; the busiest year was 2020 with 9.

0% of its events are Class I; the most common class is Class II (32). 14 events are listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
2 Dec 2025	KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P	Device	Class II	3	Ongoing
13 Nov 2025	KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K	Device	Class II	1	Ongoing
27 Jun 2025	LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)	Device	Class II	2	Ongoing
17 Jun 2025	KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L	Device	Class II	1	Ongoing
27 May 2025	KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493	Device	Class II	1	Ongoing
20 Feb 2025	Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N	Device	Class II	1	Ongoing
20 Feb 2025	Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N	Device	Class II	1	Ongoing
20 Jan 2025	Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test	Device	Class II	2	Ongoing
6 Mar 2024	KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media	Device	Class II	1	Ongoing
8 Jan 2024	Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.	Device	Class II	1	Ongoing
18 Oct 2023	KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)	Device	Class II	2	Ongoing
14 Aug 2023	KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing	Device	Class III	1	Ongoing
27 Jul 2022	Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N	Device	Class III	1	Terminated
6 May 2022	KWIK-STIK" plus: Clostridium perfringens	Device	Class III	1	Terminated
24 Mar 2022	Inactivated macrolide and quinolone-resistant Mycoplasma genitalium	Device	Class II	1	Terminated
22 Mar 2022	Inactivated macrolide-resistant Mycoplasma genitalium	Device	Class II	1	Terminated
3 Mar 2022	Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria	Device	Class II	1	Terminated
25 Feb 2022	Mycoplasma genitalium Control Panel (Inactivated Pellet)	Device	Class II	1	Terminated
20 Aug 2021	SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.	Device	Class II	1	Terminated
20 Aug 2021	SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.	Device	Class II	1	Terminated
24 Feb 2021	KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.	Device	Class III	1	Terminated
24 Feb 2021	KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.	Device	Class III	1	Terminated
16 Dec 2020	KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.	Device	Class II	1	Terminated
16 Dec 2020	KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)	Device	Class III	1	Terminated
8 Oct 2020	KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)	Device	Class III	1	Terminated
8 Oct 2020	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.	Device	Class II	1	Terminated
8 Oct 2020	Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and…	Device	Class II	3	Terminated
1 Oct 2020	KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that…	Device	Class II	3	Terminated
18 Feb 2020	KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299	Device	Class II	5	Terminated
12 Feb 2020	KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)	Device	Class II	2	Terminated
3 Jan 2020	Vaginal Verification Panel Ref 8208 Lot 8208-11	Device	Class II	1	Terminated
16 Dec 2019	Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.	Device	Class II	1	Terminated
16 May 2019	Cepheid Xpert C. difficile/Epi Control Panel	Device	Class III	1	Ongoing
9 Apr 2019	Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.	Device	Class II	2	Ongoing
31 Jan 2019	Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use	Device	Class II	1	Terminated
6 Jun 2017	Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni…	Device	Class II	5	Terminated
2 Mar 2017	KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation.…	Device	Class III	2	Terminated
1 Dec 2015	QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4.…	Device	Class II	2	Terminated
17 Jul 2015	LYFO Disk	Device	Class III	1	Completed
6 Oct 2014	KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299	Device	Class II	3	Terminated
25 Mar 2013	KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)	Device	Class III	1	Terminated
11 Feb 2013	Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.	Device	Class II	1	Terminated
29 May 2012	Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populations of known and predictable…	Device	Class II	1	Terminated

By type and class

Device43

Class II32

Class III11

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Microbiologics Inc by year initiated.

Questions and answers

How many FDA recalls has Microbiologics Inc had?

43 enforcement events (66 product records) on this register, 2012–2025: 43 device.

Are any Microbiologics Inc recalls ongoing?

14 events are listed as ongoing in the current openFDA export.

What class are Microbiologics Inc recalls?

32 Class II, 11 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.