25 results
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34ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
FDA Recall
Terminated
·Trek Diagnostic Systems·Product code JTZ·September 22, 2008
HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
FDA Recall
Terminated
·Hardy Media Inc Dba Hardy Diag·Product code GMZ·August 21, 2006
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code JTO·December 1, 2021
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·July 9, 2015
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
FDA Recall
Terminated
·Hardy Diagnostics·Product code KPA·April 16, 2021
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·December 21, 2020
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
FDA Recall
Open, Classified
·Hardy Diagnostics·Product code JSO·May 6, 2025
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
FDA Recall
Terminated
·Hardy Diagnostics·Product code KPA·May 24, 2016
FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSC·November 18, 2015
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
FDA Recall
Terminated
·Hardy Diagnostics·Product code PQZ·October 6, 2020
HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·November 14, 2019
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 24, 2015
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSJ·March 21, 2016