FDA Device recall Z-2257-2018
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is inten…
- FDA Device
- Class III
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class III recall of Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is inten… by Quantimetrix, citing the kits contained an incorrect lot of Dropper Plus Level 1 vials.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2257-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-12-21 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Quantimetrix |
| Distribution | KS |
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
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Identifiers
| code_info | Lot 44450E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2257-2018%22
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