Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The… — Class III medical device recall Z-2257-2018
Terminated recall by Quantimetrix Corporation, reported 2018-06-27, distributed in KS. The kits contained an incorrect lot of Dropper Plus Level 1 vials
| Recall number | Z-2257-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quantimetrix Corporation, Redondo Beach, CA, United States |
| Recall initiated | 2017-12-21 |
| Classified | 2018-06-20 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2021-01-27 |
| Distributed | KS |
| Quantity | 20 kits |
| Reason classes | labeling |
| Lot numbers | 44450E |
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.
Reason for recall
The kits contained an incorrect lot of Dropper Plus Level 1 vials
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-2257-2018. 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.