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Recall Observatory FDA recall evidence

Device 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.

Z-2275-2015

June 26, 2015

Class II

Product summary

Firm
Hardy Diagnostics
Event
Event 71602
Status
Terminated
Classification
Class II
Quantity
650 (65 pk/10)
Official record key
device-enforcement:Z-2275-2015

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: 15092, 15101, 15113 Cat no. G259

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.