Z-2257-2018Class III

Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care...

Name: Z-2257-2018 Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care...
Creator: Quantimetrix Corporation
Published: 2017-12-21
License: https://open.fda.gov/license/

Quantimetrix Corp. / initiated 2017-12-21 / Terminated

FDA source

Quantimetrix Corporation began a recall of 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... on 2017-12-21. FDA classified it as Class III and gives the reason as "The kits contained an incorrect lot of Dropper Plus Level 1 vials". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2257-2018
Classification: Class III
Status: Terminated
Initiated: 2017-12-21
Posted: 2018-06-20
Terminated: 2021-01-27
Recalling firm: Quantimetrix Corp.
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.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: The kits contained an incorrect lot of Dropper Plus Level 1 vials
FDA root cause: Mixed-up of materials/components
Action: Communication with their only customer for this recall was via e-mail and phone. Upon notification by the customer the following activities were initiated: All lots of the Dropper Plus product in inventory were 100% inspected. The customer was ask to return all of the kits to Quantimetrix. For further questions please call (310) 536-0006.
Quantity in commerce: 20 kits
Distribution: US Distribution to the state of : Kansas
Product codes and lots: Lot 44450E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2257-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2257-2018	Class III	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20

Product code JJW

K874890Class IQuantimetrix Urine Dipstick ControlQuantimetrix Medical Industries / cleared 1988-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)