Home / Recalls / Hardy Diagnostics / Z-2274-2015

Z-2274-2015 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
520 (26pk/20)

Product Description

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.

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: 15055, 15083, and 15091

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  • Z-2463-2015 Class II — HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Ty (July 9, 2015)