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Terminated

PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.

FDA Recall Z-1136-2010 · Posted 2010-03-15

Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeCHH
Date Initiated2009-06-05
Date Terminated2010-10-20
Product QuantityNot available.

Reason for Recall

Exhibits under-recovery of all analytes.

Firm Action

Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide and international.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023558PTS PANELS LIPID PANEL TEST STRIPSPolymer Technology Systems, Inc. · 2002-11-15K022898PTS PANELS LIPID PANEL TEST STRIPSPolymer Technology Systems, Inc. · 2002-09-24

Official Source

View FDA Recall →

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

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