10,000 results
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45ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QC TESTER
FDA Adverse Event
Malfunction
·MCGAW, INC.·Product code JTR·December 19, 1996
LYFOCULTS® PLUS CANDIDA KRUSEI
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JTR·December 10, 2015
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·March 18, 2025
Kit, Quality Control For Culture Media
FDA classification
FDA Class 1
·Kit, Quality Control For Culture Media
MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·October 12, 2007
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
FDA Recall
Open, Classified
·Microbiologics Inc·Product code JTR·October 18, 2023
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 fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·October 8, 2020
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 (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·December 1, 2015
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 24, 2021
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Recall
Open, Classified
·Microbiologics Inc·Product code JTR·December 2, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Recall
Open, Classified
·Microbiologics Inc·Product code JTR·December 2, 2025
LYFO-DISK, P. venetum, Catalog number 0794L
FDA Recall
Open, Classified
·Microbiologics Inc·Product code JTR·October 18, 2023
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.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 12, 2020
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
FDA Recall
Open, Classified
·Microbiologics Inc·Product code JTR·June 27, 2025
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
FDA Recall
Open, Classified
·Microbiologics Inc·Product code JTR·June 17, 2025
PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
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
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 18, 2020
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. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·October 1, 2020
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
FDA Recall
Open, Classified
·Microbiologics Inc·Product code JTR·May 27, 2025
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·December 16, 2020