Date Initiated by Firm |
December 21, 2017 |
Create Date |
June 20, 2018 |
Recall Status1 |
Terminated 3 on January 27, 2021 |
Recall Number |
Z-2257-2018 |
Recall Event ID |
80179 |
510(K)Number |
K874890
|
Product Classification |
Urinalysis controls (assayed and unassayed) - Product Code JJW
|
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. |
Code Information |
Lot 44450E |
Recalling Firm/ Manufacturer |
Quantimetrix Corporation 2005 Manhattan Beach Blvd Redondo Beach CA 90278-1205
|
For Additional Information Contact |
Kalyna 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 |
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 |
Total Product Life Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = JJW and Original Applicant = QUANTIMETRIX MEDICAL INDUSTRIES
|