Device recall

Z-2146-2016: QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically…

FDA device recall · Class II · Hardy Diagnostics

Key facts

Recall number (Z-number) Z-2146-2016
Recall event 74356
Product QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Product code KPA
Recalling firm Hardy Diagnostics
Recall class Class II
Status Terminated
Termination date Mar 3, 2017
FEI number 2022807

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)