Polymer Technology Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2158-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 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.

Product Classification:

Class III

Date Initiated: June 7, 2019

Date Posted: August 14, 2019

Recall Number: Z-2158-2019

Event ID: 83097

Reason for Recall:

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

Status: Terminated

Product Quantity: 559 vials

Code Information:

Lot Number: P901 Exp. Date: 8/17/2020 (01) 10304040037741 (17) 200817 (10) P901

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated