20 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·December 31, 2025
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·December 31, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·December 31, 2025
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·December 10, 2025
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·July 23, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·August 6, 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
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 18, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·February 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·February 19, 2025
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
FDA Enforcement
Class III
·Ongoing·Microbiologics Inc·September 20, 2023
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 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.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 12, 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.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 12, 2019
Cepheid Xpert C. difficile/Epi Control Panel
FDA Enforcement
Class III
·Ongoing·Microbiologics Inc·June 26, 2019
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·April 17, 2024
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·November 22, 2023
LYFO-DISK, P. venetum, Catalog number 0794L
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·November 22, 2023
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·February 21, 2024
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·April 2, 2025
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·March 26, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·August 6, 2025