Quickslide GramPro 1 Automated Gram Stanier is a microscope slide… — Class II medical device recall Z-1835-2021
Terminated recall by Hardy Diagnostics, reported 2021-06-16, distributed nationwide. Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism w
| Recall number | Z-1835-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2021-04-16 |
| Classified | 2021-06-09 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 69 units |
| Lot numbers | 1654, 1657, 1658, 1660, 1661, 1662, 1663 |
| Serial numbers | 2005, 2012, 354, 417, 422, 462, 472, 473, 480, 488, 490, 491, 496, 503, 505, 513, 521, 522, 526, 536, 551, 562, 564, 589, 590 and 44 more |
Product
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Reason for recall
Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1835-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.