Recall Z-1543-2018— Polymer Technology Systems, Inc.

Name: FDA recall Z-1543-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-14

Class II · Terminated

Class II FDA medical device recall by Polymer Technology Systems, Inc., initiated 2018-03-14, terminated 2018-09-13. It names one FDA 510(k) clearance: K041750. Product: PTS Panels¿ CHOL+GLU Test Strips (REF 1765). Reason: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018).

Recalling firm: Polymer Technology Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Terminated: 2018-09-13
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K041750 — PTS PANELS CHOL+GLU TEST PANELPolymer Technology Systems, Inc.·cleared 2004-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.