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Terminated

PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.

FDA Recall Z-0871-2010 · Posted 2010-03-01

Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeCHH
Date Initiated2009-04-02
Date Terminated2010-10-20
Product Quantity486 vials

Reason for Recall

The memory chip was coded with incorrect product information.

Firm Action

Polymer Technology Systems, Inc. issued an "Urgent - Field Correction" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product. For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990688MTM BIOSCANNER C TEST STRIPSPolymer Technology Systems, Inc. · 1999-06-24K981493MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220Polymer Technology Systems, Inc. · 1998-07-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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