Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported June 27, 2018
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
Quantimetrix Corporation recalled Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Pl… - a low-severity action.
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Pl… was recalled by Quantimetrix Corporation in June 27, 2018. Reason: The kits contained an incorrect lot of Dropper Plus Level 1 vials. Check the official notice for the remedy. Verify recall #Z-2257-2018 with the FDA Devices before acting.
The recall
Quantimetrix Corporation issued this low-severity FDA Devices recall-The kits contained an incorrect lot of Dropper Plus Level 1 vials.
- Low
- severity level
- Class III
- classification
- June 27, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2257-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
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 list the affected scope as 20 kits.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
20 kits
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| 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 |
| Firm location | Redondo Beach, CA |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2257-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Quantimetrix Corporation. Units affected: 20 kits.
Why was this product recalled? ▼
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2018. Severity: Low. Recall number: Z-2257-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the state of : Kansas.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2257-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 27, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.