FDA Medical Device Recalls (openFDA)
Polymer Technology Systems: A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
- Recall number
- Z-0683-2020
- Recalling firm
- Polymer Technology Systems
- Product
- A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
- Status
- Terminated
- Initiated
- 2016-12-02
- Posted
- not on file
- Terminated
- 2020-07-16
- Reason
- 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.
- Root cause
- Software design
- Action
- A Customer Bulletin dated November 2016 was distributed to customers.
- Quantity
- 500
- 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.
- Lot, serial or model codes
- Lot Numbers: 1610622 1618153
- 510(k) numbers
- ["K090413"]
- PMA numbers
- not on file
- Product code
- LCP
- Firm FEI
- 3002698769
- Firm city
- Whitestown
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28