FDA recall Z-1373-2019
Polymer Technology Systems, Inc. · Class II · device
Product
CHOL+HDL+GLU test strips, REF 2412
Reason for recall
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
Distribution
Domestic distribution nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2019-01-16
- Report date
- 2019-05-29
- Termination date
- 2020-06-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Indianapolis, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1373-2019