CLASS II Device recall · Reported 20 Jul 2016 · FDA Enforcement Report

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO recalled

Hardy Diagnostics is recalling QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80, distributed in 13 states. The recall was initiated on 24 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units manufactured between October 2014 and May 2016.

Quantity recalled25

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2146-2016
FDA event ID: 74356
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 May 2016
FDA classified: 8 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 May 2016	Recall initiated by company
8 Jul 2016	Classified by FDA	+45 days
20 Jul 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Arizona California Louisiana Michigan North Carolina Nebraska New Mexico New York Oklahoma Pennsylvania Texas Virginia West Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All units manufactured between October 2014 and May 2016.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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