FDA Medical Device Recalls (openFDA)
Unistrip Technologies LLC: UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
- Recall number
- Z-0855-2015
- Recalling firm
- Unistrip Technologies LLC
- Product
- UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
- Status
- Terminated
- Initiated
- 2014-11-20
- Posted
- 2014-12-23
- Terminated
- 2015-05-20
- Reason
- Failure to submit a 510(k) for device labeling changes.
- Root cause
- No Marketing Application
- Action
- UniStrip Technologies sent an Urgent Device Recall letter dated November 20, 2014, to all affected customers. They were instructed to immediately inform any of their retail accounts of the recall and have them return any of the recalled product to the distributor. The product is then to be returned to Unistrip Technologies. A reply form was included to be completed by the retail accounts and returned to the distributor who would in turn return the form to Unistrip Technologies to track returns. If you have any further questions, please call 1-866-861-8066.
- Quantity
- 7175 units
- Distribution
- US Distribution to the states of FL and OH.
- Lot, serial or model codes
- U14030713, 814031313, U140312323, and U14031413.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3010622184
- Firm city
- Charlotte
- Firm state
- NC
- 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