FDA Device recall Z-1835-2021
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer by Hardy Diagnostics, citing instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1835-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-16 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hardy Diagnostics |
| Distribution | US |
Product
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Reason
Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
Identifiers
| code_info | Lot Numbers: 1654, 1657, 1658, 1660, 1661, 1662, 1663. Serial Numbers: 354, 417, 422, 462, 472, 473, 480, 488, 490,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1835-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.