Recall Z-2157-2019 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Polymer Technology Systems, Inc.
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 l
| Date | Jun 7, 2019 |
| Status | Terminated |
| Reason | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 1,887 vials US; 2,728 vials OUS |
| Distribution | Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System Polymer Technology Systems, Inc., Dec 22, 2016 |