Recall Z-0741-2020— Polymer Technology Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Polymer Technology Systems, Inc., initiated 2016-03-15, terminated 2020-06-05. It names 2 FDA 510(k) clearances: K162282, K071507. Product: PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers. Reason: This lot of test strips is showing an under-recovery when tested against a reference method..
- Recalling firm
- Polymer Technology Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-15
- Terminated
- 2020-06-05
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K162282 — CardioChek Plus Test System, CardioChek Home Test System
- K071507 — PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
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+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Reason for recall
This lot of test strips is showing an under-recovery when tested against a reference method.
Data sourced from openFDA. This site is unofficial and independent of the FDA.