Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Recalled by Polymer Technology Systems, Inc. Due to Mislabeling

Date: June 7, 2019
Company: Polymer Technology Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Polymer Technology Systems, Inc. directly.

Affected Products

PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

Quantity: 1,887 vials US; 2,728 vials OUS

Why Was This Recalled?

The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Polymer Technology Systems, Inc.

Polymer Technology Systems, Inc. has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report