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Terminated

PTS Panels CHOL+GLU Test Strips (REF 1765)

FDA Recall Z-1543-2018 · Posted None

Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2018-03-14
Date Terminated2018-09-13

Reason for Recall

Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

Firm Action

Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots.

Root Cause

Under Investigation by firm

Distribution Pattern

OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041750PTS PANELS CHOL+GLU TEST PANELPolymer Technology Systems, Inc. · 2004-07-23

Official Source

View FDA Recall →

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

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