Polymer Technology Systems product recalled over labeling errors

Recall date

June 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Polymer Technology Systems, Inc. recalls PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel t…

Recall number

Z-2157-2019

FDA classification

Class III

Brand / firm

Polymer Technology Systems, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan

Why it was 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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.