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Recall Observatory FDA recall evidence

Device product

CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

Z-0686-2020

December 02, 2016

Class II

Product summary

Firm
Polymer Technology Systems
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

    reason.device_software_design · v1.0.0

    software bug