Class III — Quantimetrix Corporation
| Recalling firm | QUANTIMETRIX CORP. |
|---|---|
| Registered facility | QUANTIMETRIX CORP. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The kits contained an incorrect lot of Dropper Plus Level 1 vials |
| Product | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods. |
| Quantity | 20 kits |
| Distribution | US Distribution to the state of : Kansas |
| Initiated | 2017-12-21 |
| Classified | 2018-06-20 |
| Terminated | 2021-01-27 |
| Recall number | Z-2257-2018 |
| 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 III recall — Quantimetrix Corporation (Z-2257-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80179/
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