FDAFDA · Food and drugs·Recall number Z-0683-2020
A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
Published December 25, 2019 · Recall initiated: December 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Polymer Technology Systems
- Distributor
- 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.
- Lot
- Lot Numbers: 1610622 1618153
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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