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Terminated

ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

FDA Recall Z-0685-2020 · Posted None

Recalling FirmPolymer Technology Systems
Recall StatusTerminated
Product CodeLCP
Date Initiated2016-12-02
Date Terminated2020-07-16
Product Quantity20,825

Reason for Recall

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.

Firm Action

A Customer Bulletin dated November 2016 was distributed to customers.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECBayer Healthcare, LLC · 2009-05-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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