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Recall Observatory FDA recall evidence

Device 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 samples.

Z-2273-2015

June 26, 2015

Class II

Product summary

Firm
Hardy Diagnostics
Event
Event 71602
Status
Terminated
Classification
Class II
Quantity
730 (73pk/10)
Official record key
device-enforcement:Z-2273-2015

Official wording

Reason: 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.

Code information: Lot number: 15096 and 15107

Distribution pattern: U.S. Nationwide Distribution and the country of: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.