Devices

Device Recall CardioChek PTS Panels CHOLHDLGLU

Model / Serial
Lot number I904
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
Product Description
PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.
Manufacturer
Polymer Technology Systems, Inc.
1 Event
- Recall of Device Recall CardioChek PTS Panels CHOLHDLGLU

Manufacturer

Polymer Technology Systems, Inc.

Manufacturer Address
Polymer Technology Systems, Inc., 7736 Zionsville Rd, Indianapolis IN 46268-2175
Manufacturer Parent Company (2017)
Sinocare Inc.
Source
USFDA

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