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Sources: EU EUDAMED, US FDA
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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.
FDA Recall
Terminated
·Microbiologics Inc·Product code LJG·February 11, 2013
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
FDA Recall
Terminated
·Biomerieux Inc·Product code LXG·August 28, 2012
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
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 indicating how much product they had on hand.
FDA Recall
Open, Classified
·Microbiologics Inc·Product code PMN·April 9, 2019
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
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
FDA Recall
Open, Classified
·Microbiologics Inc·Product code OHQ·January 20, 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
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 indicating how much product they had on hand.
FDA Recall
Open, Classified
·Microbiologics Inc·Product code PMN·April 9, 2019
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
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
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·June 6, 2017
Vaginal Verification Panel Ref 8208 Lot 8208-11
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·January 3, 2020