Recall Z-1741-2022— Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Name: FDA recall Z-1741-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-16

Class III · Completed

Class III FDA medical device recall by Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc., initiated 2022-08-16. It names one FDA 510(k) clearance: K162282. Product: PTS Panels CHOL+GLU Test Strips (REF 1765). Reason: Incorrect instructions for use were packaged into the final product..

Recalling firm: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Classification: Class III
Status: Completed
Initiated: 2022-08-16
Firm location: Whitestown, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K162282 — CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics·cleared 2016-12-22

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

Incorrect instructions for use were packaged into the final product.

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