1,454 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO CONTROLS (HIV P24 ANTIGEN)
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code OHQ·May 27, 2022
LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 1
FDA Adverse Event
Malfunction
·BIO-RAD LABORATORIES, INC.·Product code OHQ·October 16, 2017
LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 2
FDA Adverse Event
Malfunction
·BIO-RAD LABORATORIES, INC.·Product code OHQ·October 17, 2017
LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2
FDA Adverse Event
Malfunction
·BIO-RAD LABORATORIES·Product code OHQ·November 6, 2018
VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO CONTROLS (HIV P24 ANTIGEN)
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code OHQ·June 15, 2022
RED CROSS TESTING CHAGAS DISEASE TEST
FDA Adverse Event
Injury
·UNK·Product code OHQ·July 25, 2016
Multi-Analyte Controls Unassayed
FDA classification
FDA Class 1
·Multi-Analyte Controls Unassayed
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
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
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·August 20, 2021
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Recall
Open, Classified
·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·March 3, 2022
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
FDA Recall
Open, Classified
·Microbiologics Inc·Product code OHQ·January 20, 2025
VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
FDA Recall
Open, Classified
·Biomerieux Inc·Product code OHQ·November 9, 2022
Mycoplasma genitalium Control Panel (Inactivated Pellet)
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·February 25, 2022
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·August 20, 2021
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·June 6, 2017
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code OHQ·August 1, 2022
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
FDA Recall
Terminated
·Microbiologics Inc·Product code OHQ·June 6, 2017