ClearanceBrief
Recall Z-0871-2010 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol

Polymer Technology Systems, Inc.

PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.

DateMar 1, 2010 (initiated Apr 2, 2009)
StatusTerminated
ReasonThe memory chip was coded with incorrect product information.
Root causeProcess control
ActionPolymer Technology Systems, Inc. issued an "Urgent - Field Correction" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product. For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.
Quantity486 vials
DistributionNationwide Distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K981493MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
Polymer Technology Systems, Inc., Jul 22, 1998
K990688MTM BIOSCANNER C TEST STRIPS
Polymer Technology Systems, Inc., Jun 24, 1999