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PTS Panels® Triglycerides Test Strips

POLYMER TECHNOLOGY SYSTEMS, INC. · Model 1789 · UDI-DI 00381931789012

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2
510(k) clearances
6
Adverse events
2
Recalls
28
Facilities

Description

PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

Recalls

DateFirmReason
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.