Date Initiated by Firm |
April 11, 2017 |
Create Date |
March 28, 2018 |
Recall Status1 |
Terminated 3 on August 20, 2019 |
Recall Number |
Z-1267-2018 |
Recall Event ID |
77160 |
510(K)Number |
K120497
|
Product Classification |
Calibrator, secondary - Product Code JIT
|
Product |
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet. |
Code Information |
Medica s Lot # 16292 |
Recalling Firm/ Manufacturer |
Medica Corporation 5 Oak Park Dr Bedford MA 01730-1430
|
For Additional Information Contact |
877-777-5895
|
Manufacturer Reason for Recall |
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
|
FDA Determined Cause 2 |
Process design |
Action |
Consignees were notified of the recall via email bulletin dated 4/11/17. The bulletin informs customers of the issues and explains the actions to be taken. |
Distribution |
USA: MI
FL
CA
TX
India, Russia, Puerto Rico, N. Mariana Island/Palau. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = JIT and Original Applicant = MEDICA CORP.
|