ReliOn FastA1C Test recall: Software Issue
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Why was ReliOn FastA1C Test 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: 1606319 1606405 1606460 1610622 1610910 1611163
- Product
- ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
- Recalling firm
- Polymer Technology Systems
- Quantity
- 20,825
- 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)