| Class 2 Device Recall CVS Health At Home A1C Test Kit | |
Date Initiated by Firm | December 02, 2016 |
Create Date | December 13, 2019 |
Recall Status1 |
Terminated 3 on July 16, 2020 |
Recall Number | Z-0686-2020 |
Recall Event ID |
84231 |
510(K)Number | K090413 |
Product Classification |
Assay, glycosylated hemoglobin - Product Code LCP
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Product | CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 |
Code Information |
Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153 |
Recalling Firm/ Manufacturer |
Polymer Technology Systems 4600 Anson Blvd Whitestown IN 46075
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Manufacturer Reason for Recall | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. |
FDA Determined Cause 2 | Software design |
Action | A Customer Bulletin dated November 2016 was distributed to customers. |
Quantity in Commerce | 8285 |
Distribution | The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico.
The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay. |
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 = LCP
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