Home / Recalls / Hardy Diagnostics / Z-2146-2016

Z-2146-2016 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
July 20, 2016
Initiation Date
May 24, 2016
Termination Date
March 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25

Product Description

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.

Reason for Recall

Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.

Distribution Pattern

U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.

Code Information

All units manufactured between October 2014 and May 2016.

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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)
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