Severity
Low
Quantimetrix Corporation issued this FDA Devices recall on June 27, 2018. Classified as Low severity (Class III). Approximately 20 kits units are affected. The recall was issued because: The kits contained an incorrect lot of Dropper Plus Level 1 vials. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
This FDA Devices action (record #Z-2257-2018) was formally reported on June 27, 2018, with the manufacturer initiating the action on December 21, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Quantimetrix Corporation is listed as the recalling firm, operating out of Redondo Beach, CA. Federal records indicate 20 kits units are affected.
The documented reason for this recall is: The kits contained an incorrect lot of Dropper Plus Level 1 vials Distribution data in the federal record shows the product reached: US Distribution to the state of : Kansas. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Severity
Low
Units Affected
20 kits
Related Recalls
6
6 from same agency
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.
The kits contained an incorrect lot of Dropper Plus Level 1 vials
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2257-2018 |
| Date reported | June 27, 2018 |
| Date initiated | December 21, 2017 |
| Recalling firm | Quantimetrix Corporation |
| Units affected | 20 kits |
| Distribution | US Distribution to the state of : Kansas |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
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Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).