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Recall Observatory FDA recall evidence

Device 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 samples.

Z-2274-2015

June 26, 2015

Class II

Product summary

Firm
Hardy Diagnostics
Event
Event 71602
Status
Terminated
Classification
Class II
Quantity
520 (26pk/20)
Official record key
device-enforcement:Z-2274-2015

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: 15055, 15083, and 15091

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.