Class 2 Device Recall EasyCAL HbA1c Calibrator

• Date Initiated by Firm: April 11, 2017
• Create Date: March 28, 2018
• Recall Status: Terminated 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: 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.