FDAClass IIDecember 25, 2019

Walgreens At-Home A1C Test Kit recall: Software Issue

Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

Why was Walgreens At-Home A1C Test Kit recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 1606405 1610622 1610910

Product
Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
Recalling firm
Polymer Technology Systems
Quantity
15,118
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.
Recall date
December 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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