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U.S. Department of Health and Human Services

Class 3 Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kit

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 Class 3 Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kitsee related information
Date Initiated by FirmDecember 21, 2017
Create DateJune 20, 2018
Recall Status1 Terminated 3 on January 27, 2021
Recall NumberZ-2257-2018
Recall Event ID 80179
510(K)NumberK874890 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
ProductDropper 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.
Code Information Lot 44450E
FEI Number 2020715
Recalling Firm/
Manufacturer		 Quantimetrix Corporation
2005 Manhattan Beach Blvd
Redondo Beach CA 90278-1205
For Additional Information ContactKalyna Snylyk
310-536-0006
Manufacturer Reason
for Recall		The kits contained an incorrect lot of Dropper Plus Level 1 vials
FDA Determined
Cause 2		Mixed-up of materials/components
ActionCommunication 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 Commerce20 kits
DistributionUS Distribution to the state of : Kansas
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJW
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