Hardy Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-2146-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 24, 2016

Date Posted: July 20, 2016

Recall Number: Z-2146-2016

Event ID: 74356

Reason for Recall:

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

Status: Terminated

Product Quantity: 25

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.

Voluntary or Mandated:

Voluntary: Firm initiated