Home / Recalls / Hardy Diagnostics / Z-2275-2015

Z-2275-2015 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
August 5, 2015
Initiation Date
June 26, 2015
Termination Date
September 11, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
650 (65 pk/10)

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

Lot number: 15092, 15101, 15113 Cat no. G259

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