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.
FDA Recall Z-2257-2018 · Posted None
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Recalling FirmQuantimetrix Corporation
Recall StatusTerminated
Product CodeJJW
Date Initiated2017-12-21
Date Terminated2021-01-27
Product Quantity20 kits
Reason for Recall
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Distribution to the state of : Kansas
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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