Recall Z-2146-2016— Hardy Diagnostics

Name: FDA recall Z-2146-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-24

Class II · Terminated

Class II FDA medical device recall by Hardy Diagnostics, initiated 2016-05-24, terminated 2017-03-03. FDA's recall record names no specific 510(k) clearance for this event. Product: QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.. Reason: Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient..

Recalling firm: Hardy Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2016-05-24
Terminated: 2017-03-03
Firm location: Santa Maria, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.