FDA recall Z-1543-2018

Polymer Technology Systems, Inc. · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2018-03-14
Report date
2018-05-09
Termination date
2018-09-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1543-2018