Home / Recalls / Polymer Technology Systems, Inc. / Z-1543-2018

Z-1543-2018 Class II Terminated

Recalled by Polymer Technology Systems, Inc. — Indianapolis, IN

FDA device recall Z-1543-2018 was initiated by Polymer Technology Systems, Inc. on March 14, 2018 and is designated Class II. Reason for recall: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) The recall status is terminated (terminated September 13, 2018). Affected quantity: N/A.

Recall Details

Product Type: Devices
Report Date: May 9, 2018
Initiation Date: March 14, 2018
Termination Date: September 13, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot # A705 UDI (01)00381931765016(17)180813(10)A705

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