The Recall Desk

Manufacturer

Microbiologics Inc

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

What the numbers show

Total
66
Critical
0
Severe
0
Most recent
2025-12-31

Of the 66 recalls from Microbiologics Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

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.

51–66 of 66

  • ModerateFDA (Devices)·Z-2486-2021·2021-09-29

    Microbiologics SARS-CoV-2 Process Control Pellets Recalled for Product Specification Issue

    Microbiologics Inc is recalling 218 units of SARS-CoV-2 process control pellets (catalog HE0062S) used to validate diagnostic tests. The FDA Class II recall involves product composition regarding RNA transcript content.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2021·2021-09-29

    SARS-CoV-2 Process Control Swab Recalled Due to Plasmid DNA Contamination

    Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because certain lot numbers were contaminated with plasmid DNA containing SARS-CoV-2 sequences. The affected product was distributed in the United States and internationally.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0402-2021·2020-11-11

    Microbiologics Recalls Klebsiella Pneumoniae Strain Due to Incorrect VIM-1 Status

    Microbiologics Inc is recalling 46 units of a Klebsiella pneumoniae strain because it is VIM-1 negative instead of the expected VIM-1 positive status.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Culture Units

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units that were confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    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 f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0303-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Due to Incorrect Strain

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    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 f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0304-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK 2 Pack Due to Incorrect NDM-1 Strain

    Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.

    Product
    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 f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1690-2020·2020-04-15

    Microbiologics Recalls KWIK-STIK Trichosporon Dermatis Culture Pack

    Microbiologics Inc is recalling KWIK-STIK 2 Pack Trichosporon dermatis cultures because they may contain Candida utilis instead of the labeled organism.

    Product
    KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1691-2020·2020-04-15

    Microbiologics QC Sets Recalled for Potential Mislabeling of Fungal Strains

    Microbiologics Inc is recalling QC sets that may contain Candida utilis instead of the labeled Trichosporon dermatis.

    Product
    Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2020·2020-02-12

    Microbiologics Recalls Vaginal Verification Panel Due to Contamination

    Microbiologics Inc is recalling 9 units of the Vaginal Verification Panel Lot 8208-11 because Pool 2 contains the wrong organism, Candida krusei.

    Product
    Vaginal Verification Panel Ref 8208 Lot 8208-11
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0812-2020·2020-01-22

    Microbiologics Gram-Positive Blood Culture Control Panel Recall for Hydration Fluid Change

    Microbiologics Inc is recalling 810 units of the Gram-Positive Blood Culture Control Panel because the recommended hydration fluid has changed to sterile DI water or pH 7.2 phosphate buffer.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1731-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert SA Nasal Control Panels for Shelf Life Error

    Microbiologics is recalling 235 units of Cepheid Xpert SA Nasal Complete Control Panels due to incorrect shelf life labeling.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1730-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert MRSA Control Panels Due to Incorrect Shelf Life

    Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG and Xpert SA Nasal Complete Control Panels because they have an incorrect shelf life.

    Product
    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 indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0982-2019·2019-03-13

    Cepheid Respiratory Control Panel Recalled for Reduced Expiration Date

    Microbiologics Inc is recalling Cepheid Respiratory Control Panels because the expiration date was reduced from 24 months to 13 months.

    Product
    Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2013·2013-04-03

    Microbiologics Recalls KWIK-QC Slides Due to Improper Fixation

    Microbiologics Inc is voluntarily recalling KWIK-QC Acid Fast and Mycobacterium slides because control organisms are not properly fixated, posing a contamination risk.

    Product
    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.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1936-2012·2012-07-11

    Microbiologics Recalls KWIK-QC Gram Stain Slides Due to Fixation Defect

    Microbiologics is recalling KWIK-QC Gram Stain Slides because the control organism is not properly fixated, which may lead to slide contamination and potential patient misdiagnosis.

    Product
    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 populatio
    Category
    Medical Device
    Distribution
    Distributed nationwide