Polymer Technology Systems, Inc. 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 ana Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

PTS Diagnostic issued Medical Device Recall issued letter on June 7, 2019 via certified mail, letter provides reason for recall, health risk and action to take: Immediately check your inventories and, if you have further distributed this product, please identify the users and notify them at once of this product recall. 1. Immediately check your inventories and segregate any remaining materials from lot P901.2. Distributors should immediately forward this notice and response form to all customers/users who may have received this product. 3. Acknowledge receipt of this instruction by completing the attached form, even if you do not have affected product on hand.4. If you have remaining stock of lot P901, hold that stock in quarantine. Our Customer Care team will contact you to arrange for return of the materials.