The Recall Desk

Manufacturer

Microbiologics Inc

52 recalls in our database name Microbiologics Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 52

  • HighFDA (Devices)·Z-1957-2025·2025-06-18

    KWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up

    Microbiologics Inc is recalling KWIK-STICK quality control kits because products were packaged with incorrect microorganism swabs, which may lead to delayed diagnosis of patient samples in clinical laboratories.

    Product
    KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2025·2025-04-02

    Helix Elite Quality Control Material Recalled for Delayed Detection and QC Failure

    Microbiologics Inc is recalling its Helix Elite RSV quality control material (Lot HE0044-131) because the RSV component may produce delayed test results and could fail quality control checks. This Class II recall affects 28 units distributed worldwide.

    Product
    Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1371-2025·2025-03-26

    Helix Elite SARS-CoV-2 QC Material Recall Due to Potential Ct Value Issues

    Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.

    Product
    Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2025·2025-02-19

    Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures

    Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2025·2025-02-19

    HPV Diagnostic Control Panel Recall Due to Quality Control Failures

    Microbiologics is recalling a lot of HPV diagnostic control materials due to inadequate quality control during release. The control's HPV 16 L1 concentration is too low, potentially causing test failures and invalid results in clinical laboratories.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2024·2024-04-17

    KWIK-STIK Quality Control Kit Recalled for Fungal Contamination

    Microbiologics Inc recalls KWIK-STIK quality control kits contaminated with Aspergillus brasiliensis fungus. Users may observe unexpected fungal growth when using affected control material.

    Product
    KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2024·2024-02-21

    Medical Device Control Panel Contaminated with Norovirus, Causes False Positive Results

    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) negative control is contaminated with Norovirus. Users testing this control will incorrectly receive positive Norovirus results.

    Product
    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2024·2023-11-22

    Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination

    Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.

    Product
    LYFO-DISK, P. venetum, Catalog number 0794L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2024·2023-11-22

    Medical Device Recall: KWIKSTIK Microbiological Reagent Contaminated with Aspergillus

    Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.

    Product
    KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2023·2023-09-20

    Microbiologics KWIK-STIK ANA quality control set missing strain

    Microbiologics Inc is recalling one lot of KWIK-STIK ANA QC sets missing one of three bacterial strains required for microbiological testing.

    Product
    KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1740-2022·2022-09-21

    Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution

    Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1125-2022·2022-06-01

    Medical device labeling error: KWIK-STIK® plus Clostridium perfringens

    Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.

    Product
    KWIK-STIK" plus: Clostridium perfringens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0954-2022·2022-04-27

    Medical Device Reference Standard Recalled for Inadequate Quality Control Process

    Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.

    Product
    Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2022·2022-04-27

    Inactivated Mycoplasma genitalium reference material recalled due to inadequate QC

    Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.

    Product
    Inactivated macrolide-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2022·2022-04-06

    Medical Device Manufacturer Recalls Quality Control Panel for Incorrect Shelf-Life

    Microbiologics Inc recalls the Pneumonia (33 Targets) Control Panel due to a shelf-life discrepancy. The product's shelf-life was determined to be 6 months instead of the labeled 18 months.

    Product
    Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0784-2022·2022-03-23

    Mycoplasma genitalium Control Panel Distributed Without Proper Release Testing

    Microbiologics Inc is recalling Mycoplasma genitalium Control Panel units that did not undergo proper release testing before distribution. Affected lots were distributed across the U.S. and internationally.

    Product
    Mycoplasma genitalium Control Panel (Inactivated Pellet)
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0788-2022·2022-03-23

    LYFO Disk Quality Control Product Recalled for Organism Mislabeling

    Microbiologics Inc recalls LYFO Disk lot 983-40-3 because it is labeled as Candida tropicalis but actually contains Yersinia enterocolitica. The mislabeling may cause laboratory quality control failures and delayed test results.

    Product
    LYFO Disk
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2022·2022-03-09

    Quality Control Kit Bacterial Strain Shows Unexpected Gentamicin Susceptibility

    Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide