Device product
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Z-0686-2020
Product summary
- Event
- Event 84231
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8285
- Official record key
device-enforcement:Z-0686-2020
Official wording
Reason: 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.
Code information: Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153
Distribution pattern: 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.
Derived failure modes
-
Device software or design
software bug