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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JIT
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