FDA recall Z-1741-2022
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · Class III · device
Product
PTS Panels CHOL+GLU Test Strips (REF 1765)
Reason for recall
Incorrect instructions for use were packaged into the final product.
Distribution
Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
Key facts
- Status
- Completed
- Initiation date
- 2022-08-16
- Report date
- 2022-09-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Whitestown, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1741-2022