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Recall Observatory FDA recall evidence

Device product

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

Z-2146-2016

May 24, 2016

Class II

Product summary

Firm
Hardy Diagnostics
Event
Event 74356
Status
Terminated
Classification
Class II
Quantity
25
Official record key
device-enforcement:Z-2146-2016

Official wording

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

Code information: All units manufactured between October 2014 and May 2016.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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