FDA Medical Device Recalls (openFDA)
Hardy Diagnostics: Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
- Recall number
- Z-1835-2021
- Recalling firm
- Hardy Diagnostics
- Product
- Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
- Status
- Terminated
- Initiated
- 2021-04-16
- Posted
- not on file
- Terminated
- 2022-07-28
- Reason
- Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPA
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28