FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc.: PTS Panels CHOL+GLU Test Strips (REF 1765)
- Recall number
- Z-1543-2018
- Recalling firm
- Polymer Technology Systems, Inc.
- Product
- PTS Panels CHOL+GLU Test Strips (REF 1765)
- Status
- Terminated
- Initiated
- 2018-03-14
- Posted
- not on file
- Terminated
- 2018-09-13
- Reason
- Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
- Root cause
- Under Investigation by firm
- Action
- Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots.
- Quantity
- not on file
- Distribution
- OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
- Lot, serial or model codes
- Lot # A705 UDI (01)00381931765016(17)180813(10)A705
- 510(k) numbers
- ["K041750"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3015525148
- Firm city
- Indianapolis
- 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