The Recall Desk

FDA (Devices) recall action 71602

Hardy Diagnostics recalled 7 products on 2015-08-05

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2015-08-05
Critical
0
Units
—

Why these products were recalled

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

The agency’s own wording, quoted from the enforcement report.

1–7 of 7

  • ModerateFDA (Devices)··2015-08-05

    Hardy Diagnostics Recalls MacConkey Agar and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling specific lots of MacConkey Agar and other diagnostic media because they lack FDA 510(k) clearance.

    Product
    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 s
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    0 states
  • ModerateFDA (Devices)··2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.

    Product
    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).
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    0 states
  • LowFDA (Devices)··2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiological Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.

    Product
    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 vanco
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    0 states
  • ModerateFDA (Devices)··2015-08-05

    Hardy Diagnostics Recalls Multiple Clinical Culture Media Due to Lack of Clearance

    Hardy Diagnostics is recalling several clinical culture media products, including BHI with Ciprofloxacin, because they lack FDA 510(k) clearance.

    Product
    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 sampl
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    0 states
  • LowFDA (Devices)··2015-08-05

    Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.

    Product
    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.
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    0 states
  • ModerateFDA (Devices)··2015-08-05

    Hardy Diagnostics Recalls MDR Acinetobacter and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling MDR Acinetobacter and other diagnostic media because they lack FDA 510(k) clearance.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of Clearance

    Hardy Diagnostics is recalling several microbiology media products, including BEA Broth with Vancomycin, because they lack FDA 510(k) clearance.

    Product
    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 r
    Category
    Distribution
    0 states