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.

26–50 of 52

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
HighFDA (Devices)·Z-0701-2022·2022-03-09
Helix Elite Molecular Standards recalled due to shelf life test failure
Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.
Product
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0699-2022·2022-03-09
Helix Elite Molecular Reference Standard Recall for Failed Shelf-Life Testing
Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.
Product
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0712-2022·2022-03-09
KWIK-STIK Quality Control Kit Recalled for Incorrect Antibiotic Susceptibility
Microbiologics Inc is recalling KWIK-STIK quality control kits containing Enterococcus faecalis because certain lots are susceptible to Gentamicin Synergy when they should be resistant. The defect could affect laboratory testing accuracy.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0698-2022·2022-03-09
QC Control Panels Fail Shelf Life Stability Test at 24 Months
Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.
Product
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0697-2022·2022-03-09
Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure
Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.
Product
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 derive
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0703-2022·2022-03-09
QC Control Sets for GBS Testing Recalled Due to Contamination
Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.
Product
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 (Gro
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0704-2022·2022-03-09
Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing
A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.
Product
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Grou
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0713-2022·2022-03-09
LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification
A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.
Product
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0641-2022·2022-02-23
Microbiology quality control kit recalled for incorrect inner label
A KWIK-STIK quality control kit has an incorrect inner label. The product contains Campylobacter coli, but the inner label states Haemophilus influenzae.
Product
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0584-2022·2022-02-16
KWIK-STIK Quality Control Sets recalled for potential bacterial contamination
Microbiologics Inc is recalling KWIK-STIK QC Sets and Panels due to potential contamination with E. coli and Staphylococcus species. The affected product was distributed worldwide to laboratory testing facilities.
Product
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. 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 conta
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0586-2022·2022-02-16
Diagnostic Control Microorganism Recalled for Incorrect Test Results
Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.
Product
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0587-2022·2022-02-16
QC Control Materials KWIK-STIK AST-GP Produce Incorrect Test Results
Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.
Product
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2022·2022-02-16
LYFO DISK Streptococcus Pneumoniae Culture Kit Recalled for Bacterial Contamination
Microbiologics Inc is recalling LYFO DISK Streptococcus pneumoniae microorganism culture kits (lot 947-126-1) distributed worldwide due to potential contamination with E. coli, Staphylococcus epidermidis, and S. warneri.
Product
LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorg
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0588-2022·2022-02-16
Diagnostic Quality Control Microorganism Set Fails Gentamicin Susceptibility Specifications
Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.
Product
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0589-2022·2022-02-16
QC Blood Culture Identification Panel Recall for Incorrect Antibiotic Susceptibility Test Results
Microbiologics recalls KWIK-STIK blood culture identification quality control panels due to incorrect susceptibility test results. High-level Gentamicin Synergy values were out of specification, risking inaccurate diagnostic guidance.
Product
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0585-2022·2022-02-16
Quality Control Kit for Antibiotic Susceptibility Testing Returning Incorrect Results
Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2022·2022-02-16
LYSO Disk microorganism culture device mislabeled with incorrect strain
Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.
Product
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0582-2022·2022-02-16
Medical device reference standard contaminated with bacterial species
Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.
Product
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. E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2022·2022-02-16
Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling
Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.
Product
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 desiccan
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0581-2022·2022-02-16
Medical device lot number misprinted on packaging
Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.
Product
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0544-2022·2022-02-09
Medical device control product pouches mislabeled with incorrect catalog number
Microbiologics Inc recalls KWIK-STIK IVD control product (lot 323-108-7) containing 47 packs due to pouches being labeled with incorrect catalog number 726-57-10 instead of correct labeling.
Product
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0546-2022·2022-02-09
Medical Device QC Kit Component Bears Incorrect Expiration Date Label
Microbiologics Inc is recalling KWIK-STI(TM) GBS QC Set components with a mislabeled expiration date. The Lactobacillus acidophilus component was labeled 7/31/2020 instead of 7/31/2022.
Product
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0543-2022·2022-02-09
Microbiologics KWIK-STIK Candida Parapsilosis Control Has Incorrect Pouch Labeling
Microbiologics is recalling KWIK-STIK Candida parapsilosis diagnostic controls with lot 726-57-10 because some pouches are labeled with incorrect catalog number (323-108-7 instead of 0726P).
Product
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0511-2022·2022-01-26
Microbiological Reference Products Recalled for Bacterial Contamination
Microbiologics Inc is recalling KWIK-STIK and LYFO DISK microbiological reference products contaminated with Staphylococcus epidermidis. Fifty-nine kits were distributed to multiple U.S. states and countries.
Product
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Category
Medical Device
Distribution
13 states