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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