Class II — Hardy Diagnostics
| Recalling firm | HARDY DIAGNOSTICS |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. |
| Product | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. |
| 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. |
| Initiated | 2021-04-16 |
| Classified | 2021-06-09 |
| Terminated | 2022-07-28 |
| Recall number | Z-1835-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hardy Diagnostics (Z-1835-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87850/
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