FDA-Device2019-12-25Class II
Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
Polymer Technology Systems
Hazard
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.
Sold states
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.
Affected count
15,118
Manufactured in
4600 Anson Blvd, Whitestown, IN, United States
Products
Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0684-2020Don't want to check this manually?
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