PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.
FDA Recall Z-0975-2010 · Posted 2010-04-02
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Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeCHH
Date Initiated2009-02-20
Date Terminated2010-10-20
Product Quantity3,748 vials
Reason for Recall
Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
Firm Action
Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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