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Unrated Medical device recall · FDA · Published April 16, 2021

Hardy Diagnostics Quickslide GramPro 1 Microscope Slide Stainer Recall

Hardy Diagnostics recalls Quickslide GramPro 1 microscope slide stainers with specific lot and serial numbers due to defective tubing in the pump mechanism.

🇺🇸 FDA recall #Z-1835-2021Medical deviceHardy Diagnostics ›
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Recalling firmHardy Diagnostics1430 W McCoy Ln · Santa Maria, CA 93455-1005
✎ GovInfoNow plain-language explainer

What happened, in plain English

Hardy Diagnostics is recalling specific models of their Quickslide GramPro 1 microscope slide stainers because they were assembled with defective tubing that could cause malfunction. This recall affects users who own the recalled units and may impact laboratory or educational settings where these devices are used. Read more at govinfonow.com/recall/62770-hardy-diagnostics-quickslide-grampro-1-microscope-slide-stainer-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/62770-hardy-diagnostics-quickslide-grampro-1-microscope-slide-stainer-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1835-2021

Cite this page

“Hardy Diagnostics Quickslide GramPro 1 Microscope Slide Stainer Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62770-hardy-diagnostics-quickslide-grampro-1-microscope-slide-stainer-recall. Based on FDA recall #Z-1835-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1835-2021%22&limit=1).

Why it’s dangerous

The stainers were assembled using a defective lot of tubing that is part of the pump mechanism. This defect could lead to improper functioning of the device, potentially causing inaccurate staining results or other operational issues.

Who’s affected

Users of the Quickslide GramPro 1 microscope slide stainers with the listed lot and serial numbers are affected. Laboratory professionals and educational institutions using these devices are most at risk.

How to tell if you have this one

Check the lot numbers (1654, 1657, 1658, 1660, 1661, 1662, 1663) and 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) to determine if your unit is recalled.

  • Brand
    Hardy Diagnostics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lot and Serial Numbers

    Identify your unit's lot numbers (1654, 1657, 1658, 1660, 1661, 1662, 1663) and 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) to see if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 19 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, Arkansas, California, Georgia, Kansas, Massachusetts, Michigan, Minnesota, Mississippi, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Apr 16, 202112. FDA classified it Class II: Jun 9, 202123. Published in FDA’s Enforcement Report: Jun 16, 202134. FDA terminated the recall: Jul 28, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1835-2021 (April 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1835-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA