PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.
FDA Recall Z-2641-2010 · Posted 2010-09-30
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Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2010-07-06
Date Terminated2011-05-11
Product Quantity5805
Reason for Recall
The test strips appear to under-recover Cholesterol, HDL and glucose.
Firm Action
Distributors and direct customers were notified by letter on July 2, 2010. They were told to discontinue use and dispose of the affected lot of test strips. The firm also asked customers to complete an acknowledgement and confirmation document .
Root Cause
Other
Distribution Pattern
US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
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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