Hardy Diagnostics: Medical Device Recall in 2021 - (Recall #: Z-1835-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 16, 2021

Date Posted: June 16, 2021

Recall Number: Z-1835-2021

Event ID: 87850

Reason for Recall:

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

Status: Terminated

Product Quantity: 69 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated