Z-1835-2021Class II

Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer

Name: Z-1835-2021 Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer
Creator: Hardy Diagnostics
Published: 2021-04-16
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2021-04-16 / Terminated / root cause: manufacturing process

FDA source

Hardy Diagnostics began a recall of Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer on 2021-04-16. FDA classified it as Class II and gives the reason as "Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1835-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Posted: 2021-06-09
Terminated: 2022-07-28
Recalling firm: Hardy Diagnostics
Product: Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Product code: KPA Slide Stainer, Automated
Reason for recall: Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 05/06/2021, Hardy Diagnostics issued an Urgent Medical Device Removal notice to customers via letter notifying them the GramPro 1 Automated Slide Stainer may have defective tubing, part of the pump mechanism within the unit.
Quantity in commerce: 69 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1835-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1835-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)