Kit, Quality Control For Culture Media
FDA product code JTR · Class I (low risk) · 21 CFR 866.2480 · Microbiology
12510(k) clearances
0PMA approvals
45recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871121 | Protect T.M.JTR · Traditional | Pro-Lab, Inc. | 04/14/1987SE |
| K862914 | Fekal Check Parasitology Control SlideJTR · Traditional | Trend Scientific, Inc. | 09/16/1986SE |
| K861022 | Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional | Micro-Bio-Logics | 04/04/1986SE |
| K855198 | Indi Kwik (TM) Co/Two KitJTR · Traditional | Micro-Bio-Logics | 01/14/1986SE |
| K842579 | B.E.C. Growth Chek Microbial SuspensionsJTR · Traditional | Biological & Environmental Control Laboratories | 07/27/1984SE |
| K842129 | Lyfo-Disk MicroorganismsJTR · Traditional | Micro-Bio-Logics | 07/03/1984SE |
| K831653 | Lyophilized MicroorganismsJTR · Traditional | Austin Biological Laboratories | 07/28/1983SE |
| K830133 | Q-Check Culti-LoopsJTR · Traditional | Lab Ability, Inc. | 02/09/1983SE |
| K822954 | Microtech Bacterial ControlsJTR · Traditional | Universal Micro Reference Laboratory | 11/16/1982SE |
| K821660 | Bio-Check Gram Stain ControlJTR · Traditional | American Scientific Products | 06/25/1982SE |
| K820064 | SusceptrolJTR · Traditional | American Type Culture Collection | 01/28/1982SE |
| K812698 | GC DiskJTR · Traditional | Remel Co. | 10/06/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0986-2026 Class II | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number…Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from… | Microbiologics Inc | 12/02/2025Open, Classified |
| Z-0985-2026 Class II | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog…Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from… | Microbiologics Inc | 12/02/2025Open, Classified |
| Z-0984-2026 Class II | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog…Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from… | Microbiologics Inc | 12/02/2025Open, Classified |
| Z-0876-2026 Class II | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from…Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | Microbiologics Inc | 11/13/2025Open, Classified |
| Z-2195-2025 Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LKWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target… | Microbiologics Inc | 06/27/2025Open, Classified |
| Z-2194-2025 Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF…KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target… | Microbiologics Inc | 06/27/2025Open, Classified |
| Z-2124-2025 Class II | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805LAffected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This… | Microbiologics Inc | 06/17/2025Open, Classified |
| Z-1957-2025 Class II | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella…Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing… | Microbiologics Inc | 05/27/2025Open, Classified |
| Z-1483-2024 Class II | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF…The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with… | Microbiologics Inc | 03/06/2024Open, Classified |
| Z-0308-2024 Class II | LYFO-DISK, P. venetum, Catalog number 0794LA complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus… | Microbiologics Inc | 10/18/2023Open, Classified |
| Z-0307-2024 Class II | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus… | Microbiologics Inc | 10/18/2023Open, Classified |
| Z-2576-2023 Class III | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testingOne lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. | Microbiologics Inc | 08/14/2023Open, Classified |
| Z-1125-2022 Class III | KWIK-STIK" plus: Clostridium perfringensLabeling error. | Microbiologics Inc | 05/06/2022Terminated |
| Z-0544-2022 Class III | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P.…Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. | Microbiologics Inc | 02/24/2021Terminated |
| Z-0543-2022 Class III | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per…Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. | Microbiologics Inc | 02/24/2021Terminated |
| Z-0546-2022 Class III | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component:…The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly… | Microbiologics Inc | 12/16/2020Terminated |
| Z-0511-2022 Class II | KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK…Contamination with S. epidermidis | Microbiologics Inc | 12/16/2020Terminated |
| Z-0581-2022 Class III | KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches… | Microbiologics Inc | 10/08/2020Terminated |
| Z-0402-2021 Class II | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended…Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. | Microbiologics Inc | 10/08/2020Terminated |
| Z-0304-2021 Class II | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating…QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was… | Microbiologics Inc | 10/08/2020Terminated |
| Z-0303-2021 Class II | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating…KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1… | Microbiologics Inc | 10/08/2020Terminated |
| Z-0302-2021 Class II | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating…KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1… | Microbiologics Inc | 10/08/2020Terminated |
| Z-0584-2022 Class II | QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive…Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. | Microbiologics Inc | 10/01/2020Terminated |
| Z-0583-2022 Class II | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM).…Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. | Microbiologics Inc | 10/01/2020Terminated |
| Z-0582-2022 Class II | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as…Potential contamination with S. epidermidis E. coli and S. warneri. | Microbiologics Inc | 10/01/2020Terminated |
| Z-0589-2022 Class II | QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | Microbiologics Inc | 02/18/2020Terminated |
| Z-0588-2022 Class II | QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | Microbiologics Inc | 02/18/2020Terminated |
| Z-0587-2022 Class II | QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | Microbiologics Inc | 02/18/2020Terminated |
| Z-0586-2022 Class II | LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | Microbiologics Inc | 02/18/2020Terminated |
| Z-0585-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | Microbiologics Inc | 02/18/2020Terminated |
| Z-1691-2020 Class II | Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing…KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain… | Microbiologics Inc | 02/12/2020Terminated |
| Z-1690-2020 Class II | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot…KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain… | Microbiologics Inc | 02/12/2020Terminated |
| Z-0637-2022 Class III | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit…Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Microbiologics Inc | 03/02/2017Terminated |
| Z-0636-2022 Class III | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit…Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Microbiologics Inc | 03/02/2017Terminated |
| Z-0704-2022 Class II | QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1.…The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid… | Microbiologics Inc | 12/01/2015Terminated |
| Z-0703-2022 Class II | QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1.…The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid… | Microbiologics Inc | 12/01/2015Terminated |
| Z-0788-2022 Class III | LYFO DiskLYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog… | Microbiologics Inc | 07/17/2015Completed |
| Z-0714-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack)…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | Microbiologics Inc | 10/06/2014Terminated |
| Z-0713-2022 Class II | LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | Microbiologics Inc | 10/06/2014Terminated |
| Z-0712-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | Microbiologics Inc | 10/06/2014Terminated |
| Z-0641-2022 Class III | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack…Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating… | Microbiologics Inc | 03/25/2013Terminated |
| Z-0723-2008 | PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes…Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus… | PML, Inc. dba Pml Microbiologicals Inc. | 10/15/2007Terminated |
| Z-0722-2008 | PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit…Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus… | PML, Inc. dba Pml Microbiologicals Inc. | 10/15/2007Terminated |
| Z-0721-2008 | PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes…Incorrect micro-organism-- Quality control In-vitro diagnostic test was manufactured with Cryptococcus… | PML, Inc. dba Pml Microbiologicals Inc. | 10/15/2007Terminated |
| Z-0456-2008 | MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp…Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus… | Microbiologics Inc | 10/12/2007Terminated |