PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.
FDA Recall Z-1012-2010 · Posted 2010-03-05
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Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2009-08-04
Date Terminated2010-10-20
Product Quantity962
Reason for Recall
Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.
Firm Action
Consignees were notified by letter dated 7/28/09 to discontinue use of, and to destroy, the reagent and to contact the firm for replacement product. For questions, please contact the company Customer Service toll-free at 877-870-5610 or + 1-317-870-5610 (outside the US).
Root Cause
Other
Distribution Pattern
Nationwide.
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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