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Microbiologics Inc FDA Recalls
27 recalls on file across devices, 0 of them Class I and 17 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325PClass IIDec 2, 2025Affected units may fail to recover the target microorganism |
| LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325LClass IIDec 2, 2025Affected units may fail to recover the target microorganism |
| KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325KClass IIDec 2, 2025Affected units may fail to recover the target microorganism |
| KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818KClass IINov 13, 2025Some products packaged for lot 818-111-7 may have been packa |
| LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LClass IIJun 27, 2025KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L ma |
| LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)Class IIJun 27, 2025KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L ma |
| KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805LClass IIJun 17, 2025Affected products contain Staphylococcus epidermidis instead |
| KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17Class IIMay 27, 2025Affected products were packaged with the incorrect KWIK STIK |
| Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality controlClass IIFeb 20, 2025The A549 human cell target (human cells for sample adequacy |
| Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quClass IIFeb 20, 2025The RSV target may give a late Ct value and could potentiall |
| Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnosticClass IIJan 20, 2025Internal quality control procedures were not followed correc |
| Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnClass IIJan 20, 2025Internal quality control procedures were not followed correc |
| KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culturClass IIMar 6, 2024The positive control material (Rhizopus stolonifer) within t |
| Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.Class IIJan 8, 2024The negative control was contaminated with one of the positi |
| LYFO-DISK, P. venetum, Catalog number 0794LClass IIOct 18, 2023A complaint investigation showed that the bulk pellets (lot |
| KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)Class IIOct 18, 2023A complaint investigation showed that the bulk pellets (lot |
| KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testingClass IIIAug 14, 2023One lot of KWIK STIK ANA (3 strains) QC Set is missing one o |
| Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. InactClass IIIJul 27, 2022Product not registered for use in the UK |
| KWIK-STIK" plus: Clostridium perfringensClass IIIMay 6, 2022Labeling error. |
| Inactivated macrolide and quinolone-resistant Mycoplasma genitaliumClass IIMar 24, 2022QC process was not adequate for the specification range. |
| Inactivated macrolide-resistant Mycoplasma genitaliumClass IIMar 22, 2022The QC process was not adequate for the specification range. |
| Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-QuanClass IIMar 3, 2022Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel |
| Mycoplasma genitalium Control Panel (Inactivated Pellet)Class IIFeb 25, 2022Distributed product did not undergo proper release testing. |
| SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaClass IIAug 20, 2021The SARS-CoV-2 Process Control (Pellet) contains RNA transcr |
| SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluClass IIAug 20, 2021The product indicated is contaminated with a plasmid DNA tha |
| KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD contClass IIIFeb 24, 2021Potential of products packaged for lot 323-108-7 were packag |
| KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.Class IIIFeb 24, 2021Potential that products packaged for lot 726-57-10 were pack |