CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

Quickslide GramPro 1 Automated Gram Stanier is a microscope recalled

Hardy Diagnostics is recalling Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer, distributed nationwide in the US. The recall was initiated on 16 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 1654, 1657, 1658, 1660, 1661, 1662, 1663. Serial Numbers: 354, 417, 422, 462, 472, 473, 480, 488, 490, 491, 496, 503, 505, 513, 521, 522, 526, 536, 551, 562, 564, 589, 590, 592, 596, 603, 606, 616, 620, 621, 622, 623, 624, 625, 626, 627, 628, 629, 630, 631, 632, 633, 634, 635, 636, 637, 638, 639, 640, 641, 642, 643, 644, 645, 646, 647, 648, 649, 650, 651, 652, 653, 654, 655, 656, 657, 658, 2005,2012

Quantity recalled69 units

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-1835-2021
FDA event ID: 87850
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class II
Status: Terminated
Recall initiated: 16 Apr 2021
FDA classified: 9 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Apr 2021	Recall initiated by company
9 Jun 2021	Classified by FDA	+54 days
16 Jun 2021	Published in enforcement report	+7 days

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

Reason for recall

Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.

Where it was distributed

US Nationwide distribution in the states of AK, AR, AZ, CA, GA, KS, MA, MI, MN, MS, NY, OH, PA, RI, SC, TN, TX, WI, WV.

Nationwide Alaska Arkansas Arizona California Georgia Kansas Massachusetts Michigan Minnesota Mississippi New York Ohio Pennsylvania Rhode Island South Carolina Tennessee Texas Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

Which lots are affected?

Lot Numbers: 1654, 1657, 1658, 1660, 1661, 1662, 1663. Serial Numbers: 354, 417, 422, 462, 472, 473, 480, 488, 490, 491, 496, 503, 505, 513, 521, 522, 526, 536, 551, 562, 564, 589, 590, 592, 596, 603, 606, 616, 620, 621, 622, 623, 624, 625, 626, 627, 628, 629, 630, 631, 632, 633, 634, 635, 636, 637, 638, 639, 640, 641, 642, 643, 644, 645, 646, 647, 648, 649, 650, 651, 652, 653, 654, 655, 656, 657, 658, 2005,2012

Where was it sold?

US Nationwide distribution in the states of AK, AR, AZ, CA, GA, KS, MA, MI, MN, MS, NY, OH, PA, RI, SC, TN, TX, WI, 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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