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U.S. Department of Health and Human Services

Class 2 Device Recall EasyCAL HbA1c Calibrator

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  Class 2 Device Recall EasyCAL HbA1c Calibrator see related information
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/
Medica Corporation
5 Oak Park Dr
Bedford MA 01730-1430
For Additional Information Contact
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.