Microbiologics Inc - Helix Elite - Class 2 Recall
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - LYFO Disk - Class 3 Recall
LYFO Disk (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 17, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Helix Elite - Class 2 Recall
Mycoplasma genitalium Control Panel (Inactivated Pellet) (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - LYFODISK - Class 2 Recall
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - KWIKSTIK - Class 2 Recall
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - KWIKSTIK - Class 2 Recall
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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2022 Category: Medical Devices Source Type: alerts
Hobbs Medical, Inc. - Bronchial Microbiology Brush - Class 2 Recall
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Cepheid Smart GBS QC Set - Class 2 Recall
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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Cepheid Xpert GBS QC Set - Class 2 Recall
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 (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - BD MAX - Class 2 Recall
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Helix Elite - Class 2 Recall
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 derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Helix Elite - Class 2 Recall
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 foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Helix Elite - Class 2 Recall
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Helix Elite - Class 2 Recall
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2022 Category: Medical Devices Source Type: alerts
Microbiologics Inc - KWIKSTIK - Class 3 Recall
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2022 Category: Medical Devices Source Type: alerts
